Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06029491

The Pivotal Study of RapidPulseTM Aspiration System

Led by RapidPulse, Inc · Updated on 2025-12-22

170

Participants Needed

30

Research Sites

105 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Pivotal Study of RapidPulseTM Aspiration System

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score 65 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)
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

Providence Saint John's Medical Foundation

Torrance, California, United States, 90503

Not Yet Recruiting

2

Yale University

New Haven, Connecticut, United States, 06519

Not Yet Recruiting

3

Baptist Health Research Institute

Jacksonville, Florida, United States, 32207

Not Yet Recruiting

4

University of South Florida

Tampa, Florida, United States, 33620

Not Yet Recruiting

5

Emory University at Grady

Atlanta, Georgia, United States, 30303

Actively Recruiting

6

Rush University Medical Center

Chicago, Illinois, United States, 60612

Not Yet Recruiting

7

Advocate Aurora Research Institute

Park Ridge, Illinois, United States, 60068

Not Yet Recruiting

8

Indiana University Health

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

9

State University of Iowa

Iowa City, Iowa, United States, 52242

Not Yet Recruiting

10

Washington University

St Louis, Missouri, United States, 63110

Not Yet Recruiting

11

Cooper Health System

Camden, New Jersey, United States, 08103

Not Yet Recruiting

12

State University of New York at Buffalo

Buffalo, New York, United States, 14203

Actively Recruiting

13

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Not Yet Recruiting

14

UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

15

Prisma Health

Greenville, South Carolina, United States, 29601

Not Yet Recruiting

16

Semmes Murphey Foundation - Baptist Memorial Hospital

Memphis, Tennessee, United States, 38120

Not Yet Recruiting

17

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Not Yet Recruiting

18

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, United States, 78550

Not Yet Recruiting

19

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France, 33000

Not Yet Recruiting

20

Centre Hospitalier Universitaire de Montpellier

Montpellier, France, 34295

Not Yet Recruiting

21

Centre Hospitalier Universitaire de Toulouse

Toulouse, France, 31059

Not Yet Recruiting

22

Hospital General Universitario Dr. Balmis

Alicante, Spain, 03010

Not Yet Recruiting

23

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Actively Recruiting

24

Hospital Universitari Vall d' Hebron

Barcelona, Spain, 08035

Actively Recruiting

25

Hospital Universitari de Bellvitge

Barcelona, Spain, 08907

Actively Recruiting

26

Hospital Universitari de Girona Dr. Josep Trueta

Girona, Spain, 17007

Not Yet Recruiting

27

Hospital Universitario de la Princesa

Madrid, Spain, 28006

Not Yet Recruiting

28

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Not Yet Recruiting

29

Hospital Universitario La Paz

Madrid, Spain, 28046

Not Yet Recruiting

30

Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi

Istanbul, Turkey (Türkiye), 34295

Not Yet Recruiting

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Research Team

C

Cynthia Yang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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