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