STAIR IX
Stroke Treatment Academic Industry Roundtable


October 5-6, 2015
Bethesda, MD
 

"Acute Stroke Trials: Advancing Design,

Regulation and Implementation"

 

Presentation Slides

 

MISSION, GOALS AND OBJECTIVES OF STAIR IX

Introduction - STAIR IX Chairman: Greg Albers

SESSION 1 - ACUTE STROKE TRIALS, NEW DATA, NEW LANDSCAPES, NEW DESIGNS

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

SESSION 2 - HARNESSING CRITICAL MASS TO STRENGTHEN DATA COLLECTION/ANALYSIS AND INFLUENCE GUIDELINES/REGULATORY

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

SESSION 3 - STIR IMAGING SESSION 1: ROLE OF IMAGING IN RECENT CLINICAL TRIAL

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

SESSION 4 - STIR IMAGING SESSION II: IMAGING CONSIDERATIONS FOR TRIAL DESIGN

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

SESSION 5 - REGULATORY PERSPECTIVE ON CLINICAL TRIAL ISSUES: IMAGING-BASED SELECTION, REGULATIONS AND RELEVANT POLICIES

CDER Presentation Trial Design
     Trial Efficiency and Regulations: Update on New Guidance – John Marler
     CDER Discussion on Companion Diagnostics – Larry Rodichok

CDRH Presentation on Neurothrombectomy
     Device Overview and Approaches to Medical Device Trials – Lin Zheng
     Statistical Considerations – Martin Ho
     Registries – Danica Marinac-Dabic
     Guidance for Future Studies – Lin Zheng

     CDER and CDRH Working Together to Regulate Development of New Stroke Therapies – Billy Dunn

DINNER PRESENTATION
 
NINDS STROKENET AND OTHER INITIATIVES – Walter Koroshetz, NINDS Director
 
WORKSHOPS TO DEVELOP RECOMMENDATIONS