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The Pivotal Study of RapidPulseTM Aspiration System
Sponsor: RapidPulse, Inc
Summary
The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.
Official title: The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
170
Start Date
2025-03-27
Completion Date
2027-04
Last Updated
2025-12-22
Healthy Volunteers
No
Conditions
Interventions
RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulseTM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.
Locations (30)
Providence Saint John's Medical Foundation
Torrance, California, United States
Yale University
New Haven, Connecticut, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University at Grady
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Advocate Aurora Research Institute
Park Ridge, Illinois, United States
Indiana University Health
Indianapolis, Indiana, United States
State University of Iowa
Iowa City, Iowa, United States
Washington University
St Louis, Missouri, United States
Cooper Health System
Camden, New Jersey, United States
State University of New York at Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
Prisma Health
Greenville, South Carolina, United States
Semmes Murphey Foundation - Baptist Memorial Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, United States
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Vall d' Hebron
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain
Hospital Universitario de la Princesa
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi
Istanbul, Turkey (Türkiye)