A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients

Status: Completed
Location: See all (28) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and older

• NIHSS \>=6

• The operator feels that the stroke can be treated with endovascular thrombectomy approaches and the interventionalist estimates that groin puncture can be achieved within 8 hours from time last seen well

• Pre-event mRS scale 0-1

• Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidenced by MRA or CTA

• For strokes in anterior circulation, ASPECTS \>=6; For strokes in posterior circulation, pc-ASPECTS \>=8

• Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating stroke center or outside medical facility within 2 hours of treatment initiation

• If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible

• Consenting requirements met according to local IRB or Ethics Committee

Locations
United States
Alabama
Radiology of Huntsville
Huntsville
Arizona
Carondelet Neurological Institute St. Joseph's Hospital
Tucson
California
University of Southern California
Los Angeles
John Muir Health
Walnut Creek
Florida
Baptist Health
Jacksonville
University of Miami / Jackson Memorial Hospital
Miami
Tallahassee Neurological Clinic
Tallahassee
Tampa General Hospital / University of South Florida
Tampa
Georgia
Grady Memorial Hospital / Emory University
Atlanta
Louisiana
Ochsner Health
New Orleans
Michigan
Spectrum Health
Grand Rapids
Munson Medical Center
Traverse City
New Jersey
Cooper University Health Care
Camden
New York
Montefiore Medical Center
Bronx
The State University of New York at Buffalo
Buffalo
Mount Sinai
New York
Ohio
The Ohio State University Medical Center
Columbus
Oklahoma
Oklahoma University
Oklahoma City
Pennsylvania
Lehigh Valley Hospital
Allentown
University of Pennsylvania
Pittsburgh
UPMC
Pittsburgh
South Carolina
Prisma Health - Upstate
Greenville
Tennessee
Erlanger Health System: Tennessee Interventional and Imaging Associates
Chattanooga
Semmes Murphey Foundation / Methodist University Hospital
Memphis
Texas
Baylor Scott and White Research Institute
Dallas
Valley Baptist Medical Center
Harlingen
The University of Texas Health Science Center at Houston // Memorial Hermann Health System
Houston
University of Texas Health Science Center at San Antonio
San Antonio
Time Frame
Start Date: 2021-10-01
Completion Date: 2024-05-28
Participants
Target number of participants: 328
Treatments
Experimental: Zoom Reperfusion System
The subject will undergo the endovascular thrombectomy procedure under general anesthesia or conscious sedation. The Imperative Care .088 Catheter will be used to gain access to the vasculature and direct aspiration of the clot will be attempted where feasible. The Zoom Reperfusion System must be the initial and primary device used to remove thrombus.
Related Therapeutic Areas
Sponsors
Leads: Imperative Care, Inc.

This content was sourced from clinicaltrials.gov