NIH STROKENET: ACUTE INTERVENTIONAL STROKE TRIALS
ENDOVASCULAR THERAPY FOLLOWING IMAGING EVALUATION FOR ISCHEMIC STROKE 3 (DEFUSE 3)
DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset with endovascular thrombectomy therapy vs. control. The primary endpoint, the modified Rankin Score, will be assessed at 3 months. The patients’ participation in the study concludes at that time (3 months from stroke onset). The study will randomize up to 476 patients over 4 years. The purpose of DEFUSE 3 is to assess the safety and efficacy of thrombectomy in carefully selected patients in an extended time window. Only the devices listed in this protocol will be used. Selection of the specific device (or devices) is determined by the individual endovascular therapist.
Trial Design Summary:
DEFUSE 3 is a prospective randomized Phase III multicenter controlled trial of patients with acute ischemic anterior circulation strokes due to large artery occlusion treated between 6-16 hours of stroke onset. Patients who meet the inclusion criteria will undergo either CT Perfusion/CTA or MR DWI/PWI/MRA studies prior to randomization. Patients who have evidence of an ICA or MCA M1 occlusion and a Target Mismatch Profile will be randomized in a 1:1 ratio to treatment with one or more DEFUSE 3 approved thrombectomy devices (only the devices listed in this protocol are approved for use in DEFUSE 3) plus standard medical therapy versus standard medical therapy alone. Patients who are enrolled, but not randomized, will receive standard therapy according to local guidelines. Baseline data, and information about early stroke therapies, will be captured for this group of patients.
Randomization of a maximum of 476 patients is planned. A novel adaptive design (see below) will identify, at interim analyses, the group with the best prospect for showing benefit from endovascular treatment, based on baseline core lesion volumes and the times since stroke onset. Interim analyses will be conducted at 200 and 340 patients, at which time the study may stop for efficacy/futility, or the inclusion criteria may be adjusted in the case of futility.
Study Sponsor and Chair: Gregory Albers, MD Stanford University
Protocol Director: Gregory Albers, MD - Stanford University
Protocol Director: Michael Marks, MD - Stanford University
Protocol Director: Maarten Lansberg, MD, PhD - Stanford University
The National Institute of Neurological Disorders and Stroke (NINDS) U01 NS092076
NIH StrokeNet National Coordinating Center at the University of Cincinnati
NIH StrokeNet National Data Management Center at Medical University of South Carolina
FDA, IDE: # G150028
For More information: ClinicalTrials.gov Identifier: CT02586415
Stanford University, Stanford Stroke Center
780 Welch Rd. Suite CJ350, Stanford, CA 94304
Telephone: Stephanie Kemp- 650-723-4481