The Pivotal Study of RapidPulseTM Aspiration System

Recruiting

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

Who can join

Ages 18 to 80 · All sexes

Full eligibility criteria

Inclusion 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)

Exclusion Criteria:

* 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

About the study

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.

What is being tested

RapidPulseTM Aspiration System (device)

Sponsor: RapidPulse, Inc · Participants: 170 · Started: Mar 27, 2025

Contact the study team

Cynthia Yang · Phone: 9498367402

Official record on ClinicalTrials.gov — NCT06029491

Locations in the U.S.

California	Providence Saint John's Medical Foundation, Torrance
Connecticut	Yale University, New Haven (Not yet recruiting)
Florida	Baptist Health Research Institute, Jacksonville University of South Florida, Tampa
Georgia	Emory University at Grady, Atlanta
Illinois	Rush University Medical Center, Chicago Advocate Aurora Research Institute, Park Ridge (Not yet recruiting)
Indiana	Indiana University Health, Indianapolis (Not yet recruiting)
Iowa	State University of Iowa, Iowa City (Not yet recruiting)
Missouri	Washington University, St Louis (Not yet recruiting)
New Jersey	Cooper Health System, Camden (Not yet recruiting)
New York	State University of New York at Buffalo, Buffalo Icahn School of Medicine at Mount Sinai, New York (Not yet recruiting)
Tennessee	Semmes Murphey Foundation - Baptist Memorial Hospital, Memphis (Not yet recruiting)
Texas	Valley Baptist Medical Center - Harlingen, Harlingen

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.