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Session Chairs

• Patrick D. Lyden
• Thomas Brott

Contact: James C. Grotta

Start time 2:30 p.m.
End time 5:00 p.m.

Participants

Jeffrey I. Frank
Anthony J. Furlan
James D. Gustafson
Randy Higashida
Chelsea Stella Kidwell
Thomas J. Kwiatkowski
Rose Marie Robertson
Marc Walton

Agenda

1. Device trials (Higashida)

• Trial design - small focused vs. large
• NIH funding of translational device trials including Phase 1
• FDA re-prioritization to Phase 1 safety

• Combo Therapy (Furlan)

• How to power
• How to get competing sponsors to work together
• How to select doses of each of the involved agents
• How to combine drugs and devices

• Stroke Center Designation (Kidwell)

• Medics need to take patients to designated centers
• Certification - can NIH certify?
• Should NIH recommend that some other group certify
• NIH should facilitate HCFA creating a certification

• Cooperative Clinical Trials Group (Johnson, Lyden)

• To select best trials to proceed
• Patterned after Canadian Consortium
• Select trials/sponsors/sites

• Acute stroke treatment infrastructure (Walton)

• Establish expertise and personnel
• Layer on that the research trials
• Comprehensive center to coordinate primary centers

• Clinical Trials Design (Spilker, Gustafsan)

• Need small focussed ground-breaking trials before large definitive
• Need acute (<3hour) therapy
• Need to combine with reperfusion
• Better Endpoints
• Role for Surrogate Markers
• Markers of Disease, ie the EKG for Stroke

• Diversity Issues (Johnson)

• Are minority patients less likely to be treated with t-PA
• What are the issues? Education? Infrastructure? Inner-City vs. suburban disparities in health care?
• Are strokes more severe based on race?

• Clot and Vessel Wall Interactions (Brott)

• Effect of clot on aged, non-compliant walls
• Endothelial injury mechanisms in large cerebral vessels
• What causes in-situ thrombosis

Last updated February 09, 2005