RECRUITING

The Pivotal Study of RapidPulseTM Aspiration System

Description

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.

Study Overview

Study Details

Study overview

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.

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

The Pivotal Study of RapidPulseTM Aspiration System

Condition
Acute Ischemic Stroke
Intervention / Treatment

-

Contacts and Locations

Torrance

Providence Saint John's Medical Foundation, Torrance, California, United States, 90503

New Haven

Yale University, New Haven, Connecticut, United States, 06519

Jacksonville

Baptist Health Research Institute, Jacksonville, Florida, United States, 32207

Tampa

University of South Florida, Tampa, Florida, United States, 33620

Atlanta

Emory University at Grady, Atlanta, Georgia, United States, 30303

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Park Ridge

Advocate Aurora Research Institute, Park Ridge, Illinois, United States, 60068

Indianapolis

Indiana University Health, Indianapolis, Indiana, United States, 46202

Iowa City

State University of Iowa, Iowa City, Iowa, United States, 52242

Saint Louis

Washington University, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 18 to 80 years
  • * Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
  • * Able to be treated within 8 hours of symptom onset or last known normal (LKN)
  • * Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
  • * Pre-morbid Modified Rankin Scale (mRS) score 0-1
  • * Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
  • * Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)
  • * Intracranial Hemorrhage (ICH)
  • * Alberta Stroke Program Early CT Score (ASPECTS) \<6
  • * Intracranial Atherosclerotic Disease (ICAD)
  • * Multiple or tandem occlusions
  • * Life expectancy less than 6 months

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

RapidPulse, Inc,

Raul G Nogueira, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh Medical Center Stroke Institute

Marc Ribó, MD, PRINCIPAL_INVESTIGATOR, Hospital Universitari Vall d' Hebron

Study Record Dates

2026-12