A Clinical Investigation to Evaluate and Compare the Safety and Efficacy of Using ZOOM Reperfusion Catheters and Stent Retrievers in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Stroke
- Ischemic Stroke
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: ZOOM Reperfusion Catheters are single lumen catheters that are intended to be used, in conjunction with a vacuum source, to remove thrombus in order to restore blood flow to the brain during an acute ischemic stroke. The active control treatment consists of using a mechanical thrombectomy device that is FDA cleared to improve patient functional outcome after stroke. Either Trevo® Pro (Stryker) or Solitaire™ (Medtronic) can be used upon physician's discretion.Masking: Double (Participant, Outcomes Assessor)Masking Description: 1:1 randomizationPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers. Follow-up visits will occur ...
Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers. Follow-up visits will occur at 24 hours, 3-7 days or discharge, and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.
Tracking Information
- NCT #
- NCT04129125
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital Principal Investigator: Reade A De Leacy, MD Icahn School of Medicine at Mount Sinai Principal Investigator: William J Mack, MD University of Southern California Study Director: Song Liu, MD, PhD Imperative Care, Inc.
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