The Pivotal Study of RapidPulseTM Aspiration System

NCT06029491 | Recruiting DMC FDA Device

• 1 other identifier: CIP-0002
• Study Type: interventional
• Target: 170
• Locations: 4 countries
• Sites: 30

Brief 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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Large Vessel Occlusion; Mechanical Thrombectomy; Neurovascular Intervention

Outcome Measures

Primary Outcomes (2)

• Rate of First Pass Reperfusion Effect (FPE)

  The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass

  Intra-procedural

• Rate of symptomatic intracranial hemorrhage (sICH)

  The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy

  Post-procedural (24 hours post-thrombectomy)

Secondary Outcomes (2)

• Rate of reperfusion after all study device passes

  Intra-procedural

• Modified Rankin Scale (mRS) at 90 days post treatment

  Post-procedure (90 days post-thrombectomy)

Other Outcomes (9)

• Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt

  Intra-procedural

• Final reperfusion effect

  Intra-procedural

• Time to reperfusion

  Intra-procedural

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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.

Device: RapidPulseTM Aspiration System

Interventions

RapidPulseTM Aspiration System 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.

Also known as: Aspiration Thrombectomy, Thrombectomy

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• RapidPulse, Inc: lead

Study Sites (30)

Providence Saint John's Medical Foundation

Torrance, California, 90503, United States

NOT YET RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

NOT YET RECRUITING

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

NOT YET RECRUITING

University of South Florida

Tampa, Florida, 33620, United States

NOT YET RECRUITING

Emory University at Grady

Atlanta, Georgia, 30303, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

Advocate Aurora Research Institute

Park Ridge, Illinois, 60068, United States

NOT YET RECRUITING

Indiana University Health

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

State University of Iowa

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Washington University

St Louis, Missouri, 63110, United States

NOT YET RECRUITING

Cooper Health System

Camden, New Jersey, 08103, United States

NOT YET RECRUITING

State University of New York at Buffalo

Buffalo, New York, 14203, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Prisma Health

Greenville, South Carolina, 29601, United States

NOT YET RECRUITING

Semmes Murphey Foundation - Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Valley Baptist Medical Center - Harlingen

Harlingen, Texas, 78550, United States

NOT YET RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

Centre Hospitalier Universitaire de Toulouse

Toulouse, 31059, France

NOT YET RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

NOT YET RECRUITING

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

RECRUITING

Hospital Universitari Vall d' Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

NOT YET RECRUITING

Hospital Universitario de la Princesa

Madrid, 28006, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

NOT YET RECRUITING

Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi

Istanbul, 34295, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raul G Nogueira, MD

  University of Pittsburgh Medical Center Stroke Institute

  PRINCIPAL INVESTIGATOR

• Marc Ribó, MD

  Hospital Universitari Vall d' Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Yang

CONTACT

9498367402; cyang@rapidpulsemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); TU (1); US (18); FR (3)