STAIR IX
Stroke Treatment Academic Industry Roundtable


October 5-6, 2015
Bethesda, MD
 

"Acute Stroke Trials: Advancing Design,

Regulation and Implementation"


STAIR IX Preliminary Program

 

Monday Morning, October 5

Congressional Ballroom – Main Floor of Hotel – All Meals are in the Congressional Ballroom

7:00 – 8:00         Full Breakfast Provided 

Grande Ballroom – Main Floor of Hotel – Location of all General Sessions

8:00 – 8:15         MISSION, GOALS AND OBJECTIVES OF STAIR IX

STAIR IX Chairman: Greg Albers

8:15 – 10:15        SESSION 1: ACUTE STROKE TRIALS: NEW DATA, NEW LANDSCAPE, NEW DESIGNS

Session Chairs: Marc Fisher and Jeff Saver

 

  • Update on endovascular trial results – Diederik Dippel, Michael Hill, Jeff Saver, Bruce Campbell, Tutor Jovin,        Pooja Khatri
  • Ongoing studies – Wade Smith 
  • Implications: New standard of care? Impact on future study designs – Jim Grotta
  • Getting the right patients to the right places – Lee Schwamm

    ROUNDTABLE PANEL DISCUSSION: Chairs, Speakers, Peter Rasmussen, J Mocco, Raul Nogueira, Pat Lyden, Sam Zaidat and Industry Representative

10:15 – 10:30        Refreshment Break -- Foyer Outside of Ballroom

 

10:30 – 12:15        SESSION 2:  HARNESSING CRITICAL MASS TO STRENGTHEN DATA COLLECTION/ANALYSIS AND INFLUENCE GUIDELINES/REGULATORY

Session Chairs: Joe Broderick and Tony Furlan

 

  • StrokeNet: Rationale, Overview, Objectives, Priorities, Status – Joe Broderick and Yuko Paleschy
  • Insights from large national registries (GWTG-Stroke, SITS, Canada) – Eric Smith
  • Data pooling in Acute Stroke Trials: Academic viewpoint – Ken Lees

ROUNDTABLE PANEL DISCUSSION: Chairs, Speakers, Ralph Sacco, Phil Gorelick, David Hess, Dawn Kleindorfer,

Randy Marshall and Industry Representative

12:15 – 1:00        LUNCH PROVIDED -- Congressional Ballroom – Main Floor

Monday Afternoon, October 5

Grande Ballroom – Main Floor of Hotel

1:00 – 2:15        SESSION 3: STIR IMAGING SESSION 1: ROLE OF IMAGING IN RECENT CLINICAL TRIALS Session Chairs: Maarten Lansberg and David Liebeskind

 

  • STIR I and STIR II Roadmap Summary – Steve Warach
  • Comparison of imaging selection criteria and imaging outcomes in the recent endovascular trials:

MR-CLEAN – Charles Majoie

EXTEND- IA – Bruce Campbell

ESCAPE – Bijoy Menon

SWIFT-PRIME – Greg Albers

REVASCAT – Tudor Jovin

THERAPY – Albert Yoo

ROUNDTABLE PANEL DISCUSSION: Session Chairs, Speakers and Industry Representative

 

2:15 – 3:30        SESSION 4:        STIR IMAGING SESSION II: IMAGING CONSIDERATIONS FOR TRIAL DESIGN

                Session Chairs: Max Wintermark and Tudor Jovin

  • Pooled clinical trial data: opportunities and limitations for imaging analysis  – Pooja Khatri
  • Imaging questions in need of addressing  – Bruce Campbell
  • Example of a clinical trial testing stroke imaging  – Keith Muir 

ROUNDTABLE PANEL DISCUSSION: Session chairs, Speakers, Soren Christenson and Industry Representative

 

3:30 – 3:45        Refreshment Break -- Foyer Outside of Ballroom

 

3:45 – 5:00        SESSION 5: REGULATORY PERSPECTIVE ON CLINICAL TRIAL ISSUES: IMAGING-BASED

SELECTION, REGULATIONS AND RELEVANT POLICIES

                Session Chairs: Billy Dunn FDA-CDER and Carlos Pena FDA-CDRH

  •    CDER Presentation Trial Design
  •    Trial Efficiency and Regulations: Update on New Guidance
  •    CDER Discussion on Companion Diagnostics        
  •    CDRH Presentation on Neurothrombectomy
  •    Device Review
  •    Approaches to Trial Design
  •    Considerations for Data Pooling
  •    Joint Discussion on how CDER and CDRH work together – Dunn and Pena
  •    Device and Drug packaged together
  •    Separate Drug and Device tested in combination (Add-on)
  •    Drug and Device each effective alone and used at times concomitantly
  •    Guidance for Future Studies

ROUNDTABLE PANEL DISCUSSION: Helmi Lutsep, Andrei Alexandrov, Michael Marks, Larry Wechsler

Industry and FDA – Including CDRH and CDER Representative

 

Conference Room – Main Floor of Hotel

6:30 – 7:00        SPONSORED RECEPTION

Ballroom – Main Floor

7:00 – 9:00        DINNER BANQUET -- FOLLOWED BY SPECIAL GUEST PRESENTATION

 

        “The NINDS StrokeNet and Other Initiatives – The Status and Implications”

                 — Walter Koroshetz, Acting Director NINDS   

Tuesday Morning, October 6

7:00 – 8:00        FULL BREAKFAST PROVIDED -- Conference Room – Main Floor

 

All Participants:  Please Report Directly to Your Assigned Workshop at 8 AM

 

8:00 – 10:30        WORKSHOPS TO DEVELOP CONSENSUS RECOMMENDATIONS

        Participants are divided into three groups – each to develop recommendations

 

WORKSHOP 1:        THE NEXT GENERATION OF ENDOVASCULAR TRIALS

Breakout Room        Facilitators – Chair: Tudor Jovin    Co-chair: David Liebeskind

  • Next steps following the initial positive endovascular trials: key unanswered questions
  • How to get the right patient to the right places
  • How to preserve penumbra while waiting for reperfusion

WORKSHOP 2:        IMAGING WORKSHOP: ORGANIZE A TRIAL TO COMPARE IMAGING MODALITIES

Breakout Room             TO SELECT PATIENTS FOR ACUTE STROKE TREATMENT

        Facilitators – Co-chairs: Max Wintermark, Steve Warach and Marie Luby

  • Which key imaging questions remain to be answered?
  • Which of these questions could be answered from pooling available data?
  • Which of these questions require a prospective trial?
  • Should we randomize patients or compare sites with different selection techniques?
  • How can the academic, drug, device and imaging industry work together?
  • How can a trial testing imaging selection be funded?

WORKSHOP 3:        ACADEMIC AND INDUSTRY SPONSORED TRIALS

Breakout Room        Facilitators – Chair: Ken Lees     Co-chair: Pooja Khatri

  • Competition
  • Collaboration
  • Data Pooling
  • Endpoint Selection
  • Regulatory Issues 

10:30 – 10:45        Refreshment Break   

 

10:45 – 12:00         WORKSHOP CHAIRS PRESENT RECOMMENDATIONS TO FULL ASSEMBLY

Grande Ballroom        Drafting of consensus statement is initiated – Chaired by Greg Albers

 

12:00 – 12:15        CLOSING COMMENTS AND ADJOURNMENT