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The Pivotal Study of RapidPulseTM Aspiration System

NCT ID: NCT06029491

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-27

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by a central events committee (CEC).

Conditions

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Acute Ischemic Stroke

Keywords

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Stroke Large Vessel Occlusion Mechanical Thrombectomy Neurovascular Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.

Group Type EXPERIMENTAL

RapidPulseTM Aspiration System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Aspiration Thrombectomy Thrombectomy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RapidPulse, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raul G Nogueira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center Stroke Institute

Marc Ribó, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d' Hebron

Locations

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Providence Saint John's Medical Foundation

Torrance, California, United States

Site Status NOT_YET_RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status NOT_YET_RECRUITING

Baptist Health Research Institute

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

University of South Florida

Tampa, Florida, United States

Site Status NOT_YET_RECRUITING

Emory University at Grady

Atlanta, Georgia, United States

Site Status RECRUITING

Rush University Medical Center

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Advocate Aurora Research Institute

Park Ridge, Illinois, United States

Site Status NOT_YET_RECRUITING

Indiana University Health

Indianapolis, Indiana, United States

Site Status NOT_YET_RECRUITING

State University of Iowa

Iowa City, Iowa, United States

Site Status NOT_YET_RECRUITING

Washington University

St Louis, Missouri, United States

Site Status NOT_YET_RECRUITING

Cooper Health System

Camden, New Jersey, United States

Site Status NOT_YET_RECRUITING

State University of New York at Buffalo

Buffalo, New York, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status NOT_YET_RECRUITING

UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Prisma Health

Greenville, South Carolina, United States

Site Status NOT_YET_RECRUITING

Semmes Murphey Foundation - Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status NOT_YET_RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, United States

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, , France

Site Status NOT_YET_RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

Hospital Universitari Vall d' Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari de Girona Dr. Josep Trueta

Girona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de la Princesa

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario La Paz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status NOT_YET_RECRUITING

Countries

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United States France Spain Turkey (Türkiye)

Central Contacts

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Cynthia Yang

Role: CONTACT

Phone: 9498367402

Email: [email protected]

Facility Contacts

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Sebastià Remollo, MD

Role: primary

Marc Ribo

Role: primary

Pere Cardona, MD

Role: primary

Other Identifiers

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CIP-0002

Identifier Type: -

Identifier Source: org_study_id