Attendees

·         Jen Goode

·         Paul Bishop

·         Craig Bonsignore

·         Tina Morrison

·         Achim Zipse

·         Lisa Lim

·         Steve Brooks

·         Donna Lochner

·         Ahmet Erdemir

 

Won’t be able to participate today:

·         Alexander Nikanorov

·         Lindsay Pack

·         Ahmet is planning to call in, but may be late

 

Introductory Comments

• Tech Transfer Agreements
• CDAs
• Bard CDA is completed
• Abbott, Mass General Hospital CDAs are being negotiated
• Need comments from Boston Scientific, NDC
• BSC:  may be able to get CDA soon
• MTA:  may take 3 months (protocol 1^st and then images will be included in amended MTA)
• MTA for protocol first, then images
• CCF MTA – difficulty reaching CCF Tech Transfer contact (hasn’t been getting back to Michelle)
• Lori gave her to someone else
• Bill Palmer gets stuff ready for legal
• Paul will check with Bill, and then will email Michelle to let her know what is going on
• Collective – Need to complete CDAs first

 

Status of R01 Grant (Paul)

• February 5 submission
• Draft has been received from modelers; working on again later in the week
• Shared with FDA for a meeting (Th/F are pretty open for CCF)
• Wants to send it in next week – they like 10 days to review
• Paul is working on some modeling portions
• Separate section for the ASPECT goals (2 paragraphs)
• Collaboration:  industry, academia, regulatory
• Need to see that right up at the front of the grant
• ACTION:  FDA will propose some language for edits
• Letter(s) of Support
• FDA
• Letter will state that FDA approves of Bram’s participation (co-PI) in the study & what is important about the data being collected
• Companies
• Title, number, sample letter of support (if Vik is willing to share)
• May want to send by email since web-site is open to the public
• ACTION:  Paul will provide this information and guidance on desired content of letters.
• Data sharing
• Raw data, anonynomized, quality for modeling
• DICOM
• Release to public (data sharing required by FDA)
• Protect Vik’s right of publication?  Is he okay with providing data as it is collected?
• FDA/industry look at how data is documented so that it is useful for the field
• ACTION:  Paul will check in with Vik on this issue
• Time frame for NIH review of grant
• 6 months for reviews
• Funding starts December 2010
• First enrollment likely 1-2 months after IRB approval and nursing staff
• First patient enrollment Jan/Feb 2011
• IRB:  can’t submit until protocol acceptance
• Ahmet:  usually need IRB pending status (or will bounce out of consideration)
• Check NIH guidelines
• A few hours to get the project into the CCF IRB system can follow with more formal protocol

 

Outstanding ACTION Items

• Tech Transfer Agreements – in process; need comments from companies
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build - ongoing
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)
• <$500k/year direct costs; 5 year grants (CCF has additional indirect costs)
• 4 years collecting data; 1 year of additional data analysis
• Definitions of how data was derived, so end user knows how to work with the data
• Optimize how data will be shared and readily available
• Disseminate as data is available (DICOM) and then processed
• ACTION (Paul):  Provide a working image dataset for each of the imaging types that will be used in the study – on hold until after grant application is submitted
• ACTION:  Craig & Paul (early Feb) – offline discussion

 

Next Meeting:  1/20/10 – Lisa out; Jen will run meeting.

 

Participants

Jen Goode

Lisa Lim

Steve Brooks

Marilou Bastan

Donna Lochner

Lindsay Pack

Achim Zipse

Tina Morrison

Alex Nikanorov

 

Introductory Comments

• Tech Transfer Agreements
• CDAs
• Most organizations should have received CDAs already (whoever the legal contact is)
• GOAL:  finalize in next week or 2
• Need a tech transfer person for Abbott:  whoever handles legal agreements, patent issues (usually lawyers)
• Email Lisa their contact info, and FDA tech transfer person can contact them
• Company legal folks can make edits to FDA documents, if they want
• Bard almost done (waiting on final signature)
• BSC:  haven’t heard back yet if they want any changes
• NDC:  haven’t heard back yet if they want any changes
• Abbott:  will start ball rolling on this – should be able to get done quickly
• MTA for protocol first, then images
• 1 w/CCF
• 1 w/ rest of confidential folks
• Individuals who aren’t listed as confidential participants will not be included in distribution of protocol
• First:  will share protocol
• Then:  share images
• Can’t do this until we get all CDAs signed

 

Status of R01 Grant

• February 5 submission
• Paul is working actively on the drafting of this document
• Not sure if going to NIBIB, or NHLBI
• Solid Mechanics only
• Letter(s) of Support
• FDA
• Companies?
• Might help grant if each of the companies could also write a letter of support
• Do you guys do that?
• Jen:  summary of type of letter that FDA has sent in the past
• Grant title, institute and number being applied to
• Outline need for cardiovascular disease, discuss Critical Path Issues, need for data to help with testing, device design, FDA review of new product designs
• Bard:  willing to do this, who should sign?
• FDA:  center director signature
• Abbott:  they could do this as well, need who to send to
• Logistics:
• Send as a pdf letter to Paul – they submit electronically
• What address should letter be addressed to?
• What is title of grant?
• What institute will grant be submitted to?
• What is grant number that should be cited in the letter?
• Cost:  ~$500k/year; planning to apply for a 5 year grant, but NIBIB usually funds 4 year grants
• Don’t know where the modeling section is at (Ahmet out of country, Melissa may be working on this)

 

Outstanding ACTION Items

• Tech Transfer Agreements – in process
• ACTION (Paul):  give Achim a wish list for what sizes and how many stents they’d like to have  (Melissa will help)
• Achim:  got this from Paul, so will FU with him and then will let FDA know by email what they decide
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build
• Alexander provided some drawings, so they should be able to make it very easily at CCF (2 blocks cut from polymer:  90/90 and 70/20 with adjustable height so it can work with every pt)
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)
• Don’t have details
• ACTION (Lisa):  ask Paul if there is a working image dataset for each of the imaging types that will be used in the study
• Haven’t heard back on this yet, Paul has been focussed on writing the protocol

 

Next Meeting:  1/13/10

Participants

-Lisa Lim

-Jen Goode

-Marilou Baston

-Craig Bonsignore

-Ahmet Erdemir

-Lindsay Pack

-Tina Morrison

-Brian Berg

-Andy Bicek

-Achim Zipse

-Prasanna Hariharan

-Nandini Duraiswamy

-Vijaya Kolachalama

 

 

Introductory Comments

• Tina Morrison (FDA) – helping coordinate computational modeling efforts from an FDA perspective
• Peripheral Vascular Devices Branch, FDA Office of Device Evaluation
• Fellow:  Reviewer and Research
• FDA 16 months
• CV Biomechanics at Stanford

 

Status of R01 Grant

• AHMET:
• Helping Vik to write the R01 grant
• Will use info from web-site to set up a rough draft for grant
• Then will ask ASPECT for input – what do industry/FDA need?
• What data and how it is disseminated may change – focus will be to present that they can do this?
• CCF:  collect, disseminate, do some early modeling (4-5 yr project)
• While data are being collected, can start on dissemination planning:  e.g., database set-up, etc.
• VJ:  will fluids be included in grant? Yes/No
• LISA:  primary goal will be solids
• AHMET:  no
• BRIAN: started out as a collaborative project, but CCF is taking over
• JEN:  fluids – will discuss off-line
• Sharing data sets early to look at how different groups will do the modeling
• CRAIG:  get some data now to start figuring out methods for modeling
• Single example data set – make available
• Publically?
• LISA:  those who have chosen to be confidential participants
• Once we get the legal documents in place (CDAs and MTAs), we can share the data as it is collected
• Can’t share yet with the public, but can share with the group
• CRAIG:  can we grab any data – original data set that Paul gave VJ
• Not sure if this is a full DICOM dataset (bitmap images that were uploaded) – these were IVUS
• ACTION (Lisa):  ask Paul if there is a working image dataset for each of the imaging types that will be used in the study
• CRAIG: can set up web-site to differentiate confidential participants vs. non-confidential participants
• DICOM data sets might be too big to share on Openmedsystems
• AHMET:  wrote some similar grants; Vik already has some language for clinical write-up, will add some information to the computational section
• Provide to FDA prior to grant submission – let us know if anything is missing
• TINA:
• Gathering data & building models – what images will be used
• Taking anatomical measurements; with deformations?
• AHMET:  also Gate analysis on pts – quantify longitudinal deformation in artery
• TINA:
• AAA: static CT images
• Looking at anatomical variations across patients
• Series of charts:  maximum dimensions – giving range of data
• Report on 50^th percentile, 75^th percentile diameters
• CRAIG:  sounds very complementary – should be able to learn from each other
• February 5 submission

 

Computational Modeling Protocol

• Addition of Solid Modeling (T. Morrison edits)
• Added FDA perspective on solid mechanics modeling
• Construction of a solid model of a vessel (instead of a rigid cylinder) to be used for bench and simulated testing of an SFA stent design
• Interaction of stent with vessel/plaque/fluid – many years to address all of this
• Future:  complex fluid/structure interactions
• CRAIG:  one key piece is for someone to take ownership and pull it all together  so Tina’s work on this is greatly appreciated
• Website keeps a history of everything that you do
• WIKI:  let’s “re-factor” and make a clean version of this (history will be maintained)
• SOLID MODEL:  tangible translation of anatomic clinical information into engineering terms (like Solidworks) so that it can be used
• Model:  deformable – may take a long time to do this practically
• 1^st set of examples = v. helpful to show
• Integrate images so that they are accessible to engineering community (physical tests, boundary conditions for FEM)
• TINA:  important to think about what data to share with engineers to do future modeling themselves
• CRAIG:  share data in as raw a form as possible (DICOM dataset); tabular numbers (e.g., bend radii)
• Often see numbers in tables in publications
• Hope to also have 3D data available to engineering community
• BRIAN – two important goals
• Get and distribute raw data
• An example of a model built from the data – an interpretation of all the data that was collected – informs what the mechanical environment is that the stents will “see”
• TINA:  NIH meeting today – high level discussion of model and data repositories
• AHMET:  heard Tina’s talk – v. good
• 2 NIH grants
• Disseminated some data
• Can send some example pages (including DICOM data sets)
• CCF:  can collect, can bring it into a usable form to distribute, can develop models and make them available
• Can make data available through some remote (non-CCF sites), such as Stanford Biomedical Computing Center for NIH [SIMTK]
• NIH has spent millions on these sites – will help with grant application
• üACTION (Ahmet):  during the meeting he sent the ASPECT group the web-site they use for their CCF projects (foot/musculoskeletal modeling) -https://simtk.org
• Can track who downloaded data that was disseminated
• In R01: 
• collect data,
• bring into a usable format (DICOM doesn’t require special software),
• build models – generate and disseminate geometries, and
• use for simulation,
• what will be shared & when
• CRAIG:  agree that we don’t want to reinvent infrastructure

 

Outstanding ACTION Items

• Tech Transfer Agreements – FDA is drafting
• Meeting on Friday – hope to have progress soon, so we can start sharing information
• ACTION (Paul):  give Achim a wish list for what sizes and how many stents they’d like to have  (Melissa will help)
• ACTION (Tina):  update the references to include expanded references that she is referring to (on ASPECT site) - done
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)

 

Next Meeting:  1/06/09

 

 Attendees

–        Jen Goode

–        Lisa Lim

–        Vijaya Kolachalama

–        Achim Zipse

–        Prasanna Hariharan

–        Steve Brooks

–        Donna Lochner

–        Aldo Baldano

–        Marilou Bastan

–        Paul Bishop

–        Melissa Young

–        Nandini Duraiswamy

 

Introductory Comments

• New ASPECT participants from CCF and FDA
• FDA:  Tina Morrison is going to help with computational modeling efforts from FDA perspective to make sure that any models that are developed will meet FDA needs

 

Status of R01 Grant

• Meeting with CCF Modelers
• Brian Davis, Ahmet Erdemir, Melissa Young – help to write the computational modeling section
• Have experience with solid modeling
• As Vik is writing R01 grant application:  CCF folks will add in the computational modeling information
• February 5^th submission
• Paul:  there is also a January 18^th grant that may be appropriate
• NIBIB grant

 

Computational Modeling Protocol

• Addition of Solid Modeling (T. Morrison edits)
• Not all the right people are on the call
• Tina won’t be able to attend until next week
• ACTION (All):  Ask folks to comment this week on the website and then discuss next week
• QUESTION: if anyone has problems editing on line, please let Lisa know

 

Outstanding ACTION Items

• Tech Transfer Agreements – FDA is drafting
• Working on finalizing the collective MTA for most of the participants
• ACTION (Paul):  give Achim a wish list for what sizes and how many stents they’d like to have  (Melissa will help)
• ACTION (Tina):  update the references to include expanded references that she is referring to (on ASPECT site)
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)
• PAUL:  trying to stay below 500k/year direct costs for NIH funding grant (to minimize justifications)
• For industry funding:  will budget slightly differently
• Meeting with modelers later this week to figure out how they think costs will need to be adjusted
• ACTION (everyone):  more discussion on computational modeling next week
• Brian/Melissa – have training at 4pm next Wednesday, so won’t be able to participate
• Will try to make comments on line so others can see
• Ahmet should be able to discuss

 

• Holiday plans
• Most people will be out of office for last 2 weeks, so will be hard to meet

 

Next Meeting:  12/16/09

 

Alexander Nikanorov

Lisa Lim

Craig Bonsignore

Paul Bishop

Lindsay Pack

Prasanna Hariharan

Aldo Badano

Marilou Bastan (works at CCF with Dr. Timur Sarac)

Achim Zipse

Donna Lochner

 

Introductory Comments

 

Tech Transfer Agreements – FDA is drafting

–        Decided to go with individual CDAs for different organizations that want to see proprietary data

–        MTA:  collective for those who want access to data early

 

Projected Cost of Study – Funding Possibilities

–        Estimate (from Vik):

o       Per patient cost (clinical trial only):  $13, 084

o       Per patient with indirect costs:  $20, 149 (federally funded would be higher than industry funded, not sure what number Vik gave us)

o       Database and imaging analysis: will be more (table until we figure this out): 

§         Minimum: ? (Paul will figure this out)

§         Estimated range:  ? (Paul will figure this out)

§         Database (Laurie Vivian):  flat rate (won’t be a per patient rate)

–        120 pts in IVUS study (recalling n=30 for extra imaging)

–        ACTION (Request from VIK to ASPECT): 

o       Modeling method

§         CCF Modelers: do they have time, help us with cost estimates, writing of grant application

o       Specific equipment that Vik will need to get into proper CT wedge configuration

§         Alexander:  agreed to finance (suggest that Vik develop with his engineers & radiology techs); will need one for open CT system, one for rotational CT system – they are the best ones to know what will fit in his radiology equipment

§         ACTION:  Paul will try to find out if there is someone from CCF BMEs who could work on this, will give Alexander a name

 

Imaging System Characterization – If not phantom, then ?

–        Phantom costs/complexity:  Craig hasn’t done phantom studies in the past, and got good data

–        Using stent in study:   look at macro dimensions (strut lengths, widths etc.) in the imaging systems and compare to micrometer measurements

–        IVUS/CT:  stent on table or in bucket of water

–        Expose at 37°C and then image at 25°C – dimensions shouldn’t change (Bard confirmed that this should work for the Bard stent)

–        ACTION:  Paul – let Achim know what stents he’d like

–        ALDO:  agree that this will be all you need as long as you can measure at the resolution you need for the modeling

o       IDEAL:  use CT to measure the stent b/c CT might have some limits in the measurement of small stent features, so that you can ensure that your model is representative of what you are measuring

o       Include a scale with your image

o       Calipers to measure stent on the table, and confirm with dataset from images

o       Images for IVUS, X-Ray and CT (since all will be used for model)

o       Paul:  can image IVUS at both RT and 37°C; image CT & X-Ray at RT only

 

Outstanding ACTION Items

• Tech Transfer contact information forms – complete and send to Lisa
• Everyone on this call has informed Lisa of their status (remind group members that they will be considered non-confidential and this will change their permissions on the web-site)
• Set up meeting with CCF Modeling Group – Paul
• CCF participation will affect submission of a grant, so a quick meeting would be helpful (before 12/2, if possible)

 

 

Next Meeting:  12/02/09 (No meeting on 11/25/09)

 

Participants

Jen Goode, FDA

Aldo Badano, FDA

Lisa Lim, FDA

Prasanna Hariharan, FDA

Achim Zipse, CRBard

Lisa Lim, FDA

Lindsay Pack, CRBard

Paul Bishop, CCF

Andy Bicek, BSC

Donna Lochner, FDA

Steve Brooks, FDA

 

 

Introduce FDA/OSEL participants:

–        Aldo Badano: Imaging physics lab leader, OSEL:  imaging detectors and display

–        Prasanna Hariharan:  visiting scientist with OSEL, fluid mechanics primarily, flow visualization and computational fluid dynamics

–        Nandini Duraiswamy:  solid mechanics and fatigue testing background, will also be joining but could not attend this meeting.

 

Grant Possibilities:

–        R21: 

o       lots of work;

o       only 2 years of funding;

o       hard to get a fundable score

–        R01: 

o       PAR-09-218 Innovations in Biomedical Computational Science and Technology

o       PAR-08-184 Collaborations with National Centers for Biomedical Computing

o       PAR-08-023 Predictive Multiscale Models of the Physiome in Health and Disease

–        Bioengineering Partnership Grant:  non-hypothesis, multi-team applications

–        Best advisors:  people actively submitting in these areas of interest

–        Dr. Kashyap’s new investigator status (has not received and R01 before), may help the R01 application

–        ACTION:  Paul Bishop – talks to Brian Davis (CCF) every day; will set up a call (discuss their experience)

–        PAUL

o       Spoke with a program director at NIBIB about their Training Grant program director

o       Thought this was interesting but not in her funding area

o       Thought this fell in a gray area between NIBIB and NIH

 

Imaging System Characteristics

–        To analyze images from various systems, need to control variability in images so that they can be incorporated into model

–        May need to make some image corrections in the model 

–        Is there a need for a phantom study?

o       PAUL:  will need to define errors/measurement accuracies

§         Has some data for Volcano IVUS

§         Would like to redo measurements for CT, DyneCT

o       ALDO:  would be willing to help

§         What about plain x-ray?

§         X-ray is going to be key from a resolution perspective, so these would also need to defined

§         Paul:  check in clinical environment

§         IVUS console is portable so it can be wheeled around

§         LINDSAY:  can provide some LifeStents for calibration

§         PAUL:  have some stents (but have been handled and may be altered)

·         Would be great to get some deployed but not handled

·         What size, diameter, length? How many

·         1 for reference, 1 for submerging

·         1 or 2 diameters

·         Length may not matter

·         Anything laying around would be fine

·         ACHIM:  send me a wish list

o       LISA:  are there any costs?

§         Alexander may be willing to help with funding a phantom study

§         PAUL: need to do some bench studies

·         Image of stent w/o human anatomy present

·         Load testing & visualization of stent – characterize mechanical characteristics

·         ACTION:  Paul will ask his CCF colleague what can they do in terms of bench testing, why is this needed required

·         Hot spots of imaging

§         ALDO:  could potentially also characterize with an object that shows calibration accuracy (doesn’t necessarily have to be a stent)

·         PAUL:  have some phantoms for IVUS, can look to see if they have anything for CT

·         JEN:  same object across various imaging systems; complex geometry/near vs. far side

·         ANDY:  would you need gray scale image of detector; noise levels

·         ALDO:  maybe not, but distances/angles may be more important for this study(not so much noise, gray scale); have done a lot of this for CT/Xray, but not much for linear measurements

·         ANDY:  would be nice to have same object across images, but each modality may require something slightly different b/c of physics

o       Make a map for each machine and use this for key

·         ACTION:  Paul/Aldo – details of IVUS phantom; discuss off-line some available CT phantoms to see if these will work

·         ACTION:  Jen will add Aldo’s info to contact page

 

Outstanding ACTION Items

–        Tech Transfer contact information forms – complete and send to Lisa

–        Get legal documents in place - Lisa

–        Ask Vik for projected cost of study – Lisa

o       Paul:  New innovator hadn’t required cost estimates, so they hadn’t really pulled anything together

o       ACTION:  Paul will pull together imaging costs & have asked CCF database trials costs

o       Divide total number by 6

o       Ballpark estimates will help companies consider whether or not they are willing to fund

–        Ask Vik for copy of protocol – Lisa

o       ACTION:  Will see if he is willing for us to share (won’t be on ASPECT web-site)

–        No meeting next week:  Federal holiday

–        ACTION:  PAUL is willing to share pt dataset with FDA as well

o       is below 10MB (may be able to email) – PAUL can send images to ALDO

o       Bitmap of IVUS cross sections (pixels/mm)

o       Also includes color coded tissue imaging

 

 

Next Meeting:  11/18/09 (No meeting on 11/11/09, Veteran’s Day)

 

Attendees

Achim Zipse

Craig Bonsignore

Lindsay Peck

Vijaya  Kolachalama

Lisa Lim

Jen Goode

Steve Brooks

Vik Kashyap

 

–         Grant situation:  deadline for the New Innovator was 10/27

–         Vik didn’t apply after discussions with contacts at NHLBI (didn’t expect it could be funded through their group)

–         Vik:  suggested including these goals as secondary goals in another study that could get funded

–         Donna Lochner got other contact names through Tim Baldwin at NIH.  She shared this contact information with Vik Kashyap

–         Enthusiasm for different imaging modalities and novel data that would be obtained

o        NEED:  confirmation or refutation of a hypothesis

o        e.g., what stent characteristic is associated with a type of plaque morphology

–         CRAIG:  were considering an observational study instead of a hypothesis testing trial

o        Could develop a hypothesis

–         Donna talked with Tim Baldwin and there is an avenue through NHLBI:  Bioengineering Grant: that this type of research is appropriate for

o        Vik will FU with Brian at CCF Lerner Center and look into bioengineering grant

–         Non-confidential list: if you don’t reply

o        Can change website to limit reading vs. making changes on site

–         Wedge information from Alexander:  engineering could construct, but no specifics were provided from Stanford

–         Deficiency:  how is this data going to move treatment of CV disease forward

o        Will help with design and testing

o        Then why aren’t companies funding studies – commercially funded – control data – some have it and some don’t

o        Public health issue – lots of stent thrombosis – poorly designed stents – not sure this is true (might limit company involvement)

o        Unknown – identify forces; see if bench testing is predictive; improve design more quickly; get to market more quickly

§         1 year data might not be enough…

o        Variability of data across patients – company funded might not get enough patients

–         How much money is needed total – divide by 6 and ask the companies

o        Might be a challenge to get buy off from money folks at companies to get them to pay and be willing to share…

o        ACTION:  Lisa will ask Vik for costs so these can be shared with the companies

o        Design decisions based on analyses is proprietary to the company

o        Common when a company signs up with an investigator – clinician wants to publish/company also will want a say in how data is published

o        Kashyap:  first publications; right to review other publications

o        ACTION:  Lisa will ask Vik to share grant with companies willing to consider paying into the project (especially if legal agreements in place)

§         Won’t share with others

§         Will help to have agreements in place

§         ACTION:  Lisa – Tech transfer on Friday with Michelle

 

 

Lindsay Pack

Paul Bishop

Alexander Nikanorov

Lisa Lim

Vijaya Kolachalama

Steve Brooks

Brian Berg

Andy Bicek

Donna Lochner

 

Not able to participate today:

Achim Zipse

 

Introductory Comments

 

Tech Transfer Agreements

• ASPECT organizational structure:  “confidential” vs. “non-confidential” participants
• Companies:  All or none? (early data/modeling)
• Abbott: would like to work with early data
• Sign up as interested – OK with BSC, Bard
• ACTION (LISA):  will figure out how to do this with FDA (Michelle)
• Tech transfer:  academic institutions, FDA

 

October 9 Discussion with Vik Kashyap

• Minimum imaging for stented vs. unstented, straight and bent, anatomical motion for engineers to determine forces with leg motion

o       Pre-procedure CTA

o       During stenting procedure:  IVUS and DyneCT after stent placement (straight and bent positions)

o       12 month FU (all patients):  CT w/o contrast (straight and bent)

o       Reinterventions (if necessary):  IVUS and DyneCT (straight and bent)

o       Bent configuration:  randomize to 70/20 vs. 90/90 (achieved using preformed wedges), measure what is actually achieved (using a protractor)

§         Brian:  If 70/20 or 90/90 is problematic (which may be true for DyneCT), could do Figure 4 – Vik was amenable to this

• NIH New Innovator Grant Application

o       Incorporate Craig’s justification

o       Draft completed by October 16

o       Due October 27

• R01 Grant Application

o       Will need to submit while awaiting decision on New Innovator

• Need the details on the wedges used in the Stanford studies

ACTION ITEM:  Alexander – will FU with Dr. Kashyap on this

o       Wasn’t able to contact them yet – think engineers at CCF can make this (he’ll talk to Dr. Kashyap); Abbott willing to give money to CCF to do this

 

·         PAUL:  put up images of DynaCT

o       In vivo SMA stent – DICOM data set

o       Engineers agreed that resolution is great

o       Going to do an SFA stent patient in the next few weeks

o       ACTION:  request if data file can be sent to Alexandar (DICOM)

 

·         PAUL:  looks like he’ll have data on radial pulsatility

o       N=10 pts

o       Tissue composition

o       Comment on concentricity/ovalness of vessel

o       BRIAN:  wonderful data to have

o       Will touch base with some folks on how they’d like to see data set

 

Outstanding ACTION Items

• Revise justifications for endpoint imaging and how this will be used for computational modeling (Craig)
• Tech Transfer contact information forms – complete and send to Lisa

 

Next Meeting:  10/28/09 (No meeting on 10/21/09 – Jen and Lisa at VIVA)

Comment added on 10/14/09

 

PARTICIPANTS:

·         Jen Goode

·         Paul Bishop

·         Lisa Lim

·         Brian Berg

·         Vijaya Kolachalama

·         Lindsay Pack

·         Achim Zipse

·         Craig Bonsignore

·         Alexander Nikanorov

·         Steve Brooks

·         John Muskivitch

·         Kyle Myers

 

Introductory Comments:

 

Tech Transfer Agreements:

• Why do we need these agreements?
• Protect CCF’s interest as collector of data
• CDA:  collective for entire group except CCF
• Separate CDA with CCF
• MTA:  material transfer agreement
• Data from CCF to FDA, share with ASPECT
• Open source at end
• NDC & FDA:  Expectation is that at the end the raw data is available to the community at the end
• External funding sources
• Legal agreements:  external funding sources – may have some publication issues as well
• BSC:
• Brian sent some stuff – but legal group didn’t want to send anything until they saw a draft contract
• Brian sent some BSC research and education grant contact info (unrestricted grant)
• Bard:  unrestricted terminology – can use it for anything you want; restricted – has to be used for this project
• Would have to be unrestricted b/c final data for ASPECT is intended to be public

 

Recap of Feedback from Vik Kashyap

• R21 Endpoint Objectives
• Discussed Endpoint Objective table with Vik
• Concerns about repeat imaging (straight/bent and at all FU) b/c of CT dosing
• If symptomatic:  get FU imaging then
• Take what we can get
• May not be much to analyze stent incorporation
• For invasive imaging
• Xrays:  2 planes & 2 positions – everyone at procedure and 12 months, OK to get invasive images at procedure and FU for symptomatic pts (straight and bent)
• 90/90 – hard to get 90 at hip for IVUS/CT
• 1 CTA at 12 months with straight (get stent and patency
• CT without contrast with flexed knee (90 at knee, large pts may not be able to get 90 at hip and fit in)
• Cross legged position – standardized position (figure 4 UColarado study) – did a C-arm study
• ACTION:  Alexander will post on web-site
• Not an invasive procedure:  minimize contrast (12 months later – case by case)
• More radiation for CT than Xray
• Better imaging with CT than Xray
• Plain xrays – enough info on image intensifier and sensor to get magnification factor
• DUS: patency – CTA more accurate at this point
• Then straight & bent w/o contrast
• 90/90 only – angle of deflection should be recorded
• Hip rotation in plane – may not be able to get 90 at hip
• 70/20 not looking at right now?
• More radiation/contrast = more severe
• What is he willing to do in all pts?
• What is he willing to do in symptomatic pts?
• Why straight?
• Baseline for stent to define change to bent leg
• Elongation/straightening – calculating % deformations at 90/90
• Some at 90/90, some at 70/20 (n=12-15 each)
• Stent length and position in artery could impact results
• Use longest stent length
• Need cross section for bending loading
• Consensus:  15 pts in 70/20, 15 pts in 90/90
• No contrast in CT at all
• Don’t want small pts in 90/90 group
• Randomize 70/20 vs. 90/90 (get as close as you can – record angles)
• Why patency?
• Don’t need contrast for patency in CT (Alex is okay with giving this up)
• DyneCT – angio equipment – looks like CT (but not good enough resolution for this application)
• Not sure you can use same equip at FU
• Resolution needed:  <1mm; DyneCT:  10mm resolution
• Need 64 slice CT to see stent at FU
• If DyneCT can get <1mm resolution; 3D reconstruction? Measurement functions

See attached file created by Craig.  It is a listing of imaging modalities organized in order of increasing "invasiveness".

• External Sources of Funding

 

 

Protocol Updates – Comments?

• Make sure everything is captured

 

Outstanding ACTION Items

• Write up justifications for endpoint imaging and how this will be used for computational modeling (Achim, Craig and John)
• 1 pager
• 1 week turn around
• ACTION:  ask Donna about adding slides to web-page from June 2 conference
• Put FDA talks up
• Email presenters – they can opt in if they’d like
• Paul:  believes that data set given to Ahmet at CCF is same one that was given to Vijaya

 

Next Meeting:  10/07/09

 

• New investigator grant:  3 people working on this at CCF
• ACTION:  FDA letter of support

 

 

Participants:

·         PJennifer Goode

·         PLisa Lim

·         PSteve Brooks

·         PJohn Muskivitch

·         PAchim Zipse

·         PKyle Myers

·         PDonna Lochner

 

Can’t attend:

·         Paul Bishop

·         Craig Bonsignore

·         Lindsay Pack @TCT

 

Introductory Comments

• Jen, Donna, and Lisa spoke with Vik Kashyap today

 

Feedback from Vik Kashyap

• R21 – Discussed Endpoint Objectives Table
• Dr. Kashyap has concerns about
• CT dosing for repeat imaging (straight vs. bent) & at FU
• 70/20 and 90/90 – patients (imaging fixture)
• FU only if symptomatic
• ACTION:   write up justifications for endpoint imaging and how this will be used for computational modeling
• John will work with Craig & Achim to see what they can do (can set up a call)
• CT resolution compared to IVUS
• DynaCT – now have this system, does it have enough resolution, could it be useful here?
• May not have FDA approval in US
• External Sources of Funding
• Interested
• Asked him how much funding would be needed?
• Dr. Kashyap seemed more focussed on adding to the R21 grant

 

FU:  at procedure & then if symptoms

·         Dr. Kashyap:  only FU with invasive imaging post-procedure if symptoms

·         Desire:  consistent time point

·         Any data (even if at different times) would be informative

 

Leg configuration

·         Fixture for:  90/90 and 70/20

·         Not sure how you could do this on the table

·         Access from contralateral (staying straight)

·         Might have interference from other leg bone

·         Not sure if you can get a c-arm image intensifier high enough to image the leg?

o       Puts a lot of radiation in the room

o       CT-scanner may be better way to go

·         Kyle: some systems – limited angle CT (just for this type of purposes – just a few research systems

·         Open CT’s (where they aren’t in a donut) – may be able to do this

·         ACHIM:  90 leg should work, but less than 90° hip – capture on a form

o       Should be able to get this in the cath lab or with a CT with donut

o       What happens with:   Only hip vs. only knee flexure (future studies)

§         Cath lab could see if only knee mandated

§         Cath lab could look at hip only if flat on table (but adds a rotation)

o       90/90:  sitting

o       70/20:  walking

o       ACTION:  ask others next week

 

Protocol Updates

·         Achim thought changes were consistent with endpoint objectives table

·         John’s comments showed up on web-site

 

 

 

Next Meeting:  9/30/09