Solitaire With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial "SWIFT PRIME"

Completed

Phase N/A Results N/A

Trial Description

This study is to determine if patients experiencing an Acute Ischemic Stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire FR within 6 hours of symptom onset have less stroke-related disability than those patients treated with IV t-PA alone.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 90-day global disability assessed via the blinded evaluation of modified Rankin score (mRS). 90 days No
Secondary Death due to any cause at 90 days 90 days Yes
Secondary Functional independence as defined by modified Rankin Scale (mRS) score ≤2 at 90 days 90 days No
Secondary Change in NIH Stroke Scale score at 27 ±3hrs post randomization 27 hrs No
Secondary Change in NIH Stroke Scale score at 27 ± 6 hrs post randomization 27 hrs No

Sponsors