STAIR VIII
Stroke Treatment Academic Industry Roundtable

March 9-10, 2013
Washington D.C.
 

"Accelerating the Evolution of Stroke Therapy"

STAIR VIII Program

Saturday Morning, March 9

7:00 – 8:00     Full Breakfast Provided   

8:00 – 8:15     MISSION, GOALS AND OBJECTIVES OF STAIR VIII
                          STAIR VIII Chairman: Greg Albers

8:15 – 10:15    SESSION 1: UPDATE ON ENDOVASCULAR REPERFUSION TRIALS
                           Session Chair: Marc Fisher    Co-chair: Larry Wechsler

• What did we learn from IMS III? – Joe Broderick
• Imaging-based Studies: MR Rescue, DEFUSE 2, TNK, DIAS – Chelsea Kidwell
• What do SWIFT and TREVO 2 tell us about stent-trevors – Raul Nogueira
• Study designs and endpoints in ongoing endovascular trials –  Wade Smith

              ROUNDTABLE PANEL DISCUSSION: “WHAT ARE THE OPTIMAL DESIGNS FOR ENDOVASCULAR TRIALS?”
                                 George Howard, Michael Marks, Reza Jahan, Pooja Khatri, Jamie Wheeler (Stryker)

10:15 – 10:30    Refreshment Break

10:30 – 12:15    SESSION 2: STROKE IMAGING RESEARCH ROADMAP (STIR)                           
                              Session Chair: Steve Warach    Co-chair: Jochen Fiebach

• Defining salvageable tissue and collaterals – Mark Parsons
• Imaging of recanalization and reperfusion – Andrew Demchuk
• Imaging based selection for clinical trials – Ken Lees
• Clinical translation of advanced imaging techniques for stroke – Ona Wu

     ROUNDTABLE PANEL DISCUSSION: “DOES THE ROADMAP LEAD TO THE RIGHT DESTINATION?”
         Joe Broderick, Jens Fiehler, Tudor Jovin, Ken Lees, Michael Lev, Joanna Wardlaw

12:15 – 1:15    LUNCH PROVIDED

Saturday Afternoon

1:15 – 2:45    SESSION 3: NEW ORAL ANTICOALGULANTS: UNRESOLVED ISSUES & NEXT STEPS
                         Session Chair:  Don Easton    Co-chair: Philip Gorelick

• Pros & cons of individual agents based on large trial results: RELY, ROCKET, ARISTOTLE, AVERROES – Ralph Sacco
• Unresolved Issues: Monitoring anticoagulant effects, Reversal agents, Compliance, Concomitant use of reperfusion therapies, Phase 4 observations – John Eikelboom
• What clinical trials are needed next? - Prevention of non-CE stroke?  High risk TIA? – Michael Hill

           ROUNDTABLE PANEL DISCUSSION:  Robert Croop (BMS), David Hess, Jeffrey Friedman (BI)

2:45 – 3:00    Refreshment Break

3:00 – 5:00    SESSION 4: REGULATORY ISSUES RELEVANT TO STROKE TREATMENT AND PREVENTION TRIALS
                         Session Chair: Billy Dunn, FDA-CDER     Co-chair: Quynh Hoang, FDA-CDRH

• IV tPA in the 3-4.5 hour window: data analysis and US regulatory submission – Susan Begelman, Genentech
• Regulatory Challenges for Endovascular Trials – Stacey Pugh, Covidien Neurovascular
• Current FDA Expectations for Endovascular Trials – Larry Rodichok FDA-CDRH
• Oral Anticoagulants: New Regulatory Considerations – Marty Rose FDA-CDER

           ROUNDTABLE PANEL DISCUSSION:  “REGULATORY CONSIDERATIONS AND PERSPECTIVES
           ON STUDY DESIGN FOR STROKE TREATMENT DEVICES AND NEW ANTICOAGULANTS"
                             Jonathan Megerian (Codman/J&J), Yoram Solberg (Brainsgate), Werner Hacke, Andy Weiss (CoAxia),  
                             Arani Bose (Penumbra) Representatives from oral AC companies TBD

Discussion points will include:
        1. Outcome/endpoint analysis; shift vs. dichotomization vs. sliding dichotomy
        2. Minimal effect size considered clinically relevant (drug and device divisions)
        3. Comparing devices or other drugs to tPA:
              a. Ramifications of lack of tPA regulatory approval in 3-4.5 hr. window
              b. Use of IV and IA tPA in future device trials
        4. US vs. non-US trial data: acceptability of foreign data for US regulatory approvals
        5. Regulatory implications and solutions for inclusion of multiple devices/combination therapies in trials

6:30 – 7:00     SPONSORED RECEPTION

7:00 – 9:00    DINNER BANQUET -- FOLLOWED BY NINDS PRESENTATION:                                                               
                       “The NINDS Stroke Research Planning Effort – The Results and the Implications”
                        -- Story Landis, Director, NINDS and Walter Koroshetz, Deputy Director, NINDS

Sunday Morning, March 10

7:15 – 8:00    FULL BREAKFAST PROVIDED

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:     RECOMMENDATIONS FOR ENDOVASCULAR THERAPIES
                                  Endovascular Trials: Clinical and Regulatory Issues
                                  Facilitators – Chair: Jeffrey Saver    Co-chair: Tudor Jovin

WORKSHOP 2:     RECOMMENDATIONS FOR IMAGING
                                  Stroke Imaging Research Roadmap  (STIR)
                                  Facilitators – Chair: Max Wintermark   Co-chair: Jim Grotta

WORKSHOP 3:     RECOMMENDATIONS FOR NEW ORAL ANTICOAGULANTS
                                  Current Issues, Future Trials & Regulatory Concerns
                                  Facilitators – Chair: Karen Furie    Co-chair: Bob Hart

10:30 – 10:45        Refreshment Break

10:45 – 12:00        WORKSHOP CHAIRS PRESENT RECOMMENDATIONS – General Discussion
                                  Drafting of consensus statement is initiated – Chaired by Greg Albers

12:00 – 12:15        CLOSING COMMENTS AND ADJOURNMENT