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New pulsed suction device aims to clear stroke clots faster

NCT ID NCT06029491

Disease control Sponsor: RapidPulse, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests a new device called the RapidPulse Aspiration System, which uses precisely timed suction to remove blood clots from brain arteries in people having a severe stroke. The trial will enroll 170 adults aged 18 to 80 who can be treated within 8 hours of stroke symptoms. The goal is to see if the device can safely restore blood flow in one pass and improve recovery at 90 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RapidPulse Aspiration System (a device that uses pulsed suction to remove blood clots from brain arteries)
What this could lead to
If successful, this device could become a standard first-line treatment for acute ischemic stroke, potentially improving recovery and reducing disability.
What could go wrong
This is a pivotal study with 170 participants, but it is not yet approved. The device may not work for all clot types, and there is a risk of bleeding in the brain or other complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Aurora Research Institute

    NOT_YET_RECRUITING

    Park Ridge, Illinois, 60068, United States

  • Baptist Health Research Institute

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Centre Hospitalier Universitaire de Bordeaux

    NOT_YET_RECRUITING

    Bordeaux, 33000, France

  • Centre Hospitalier Universitaire de Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • Centre Hospitalier Universitaire de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Cooper Health System

    NOT_YET_RECRUITING

    Camden, New Jersey, 08103, United States

  • Emory University at Grady

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Universitari Germans Trias i Pujol

    RECRUITING

    Badalona, 08916, Spain

  • Hospital Universitari Vall d' Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    Barcelona, 08907, Spain

  • Hospital Universitari de Girona Dr. Josep Trueta

    NOT_YET_RECRUITING

    Girona, 17007, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario de la Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Icahn School of Medicine at Mount Sinai

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • Indiana University Health

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi

    RECRUITING

    Istanbul, 34295, Turkey (Türkiye)

  • Prisma Health

    WITHDRAWN

    Greenville, South Carolina, 29601, United States

  • Providence Saint John's Medical Foundation

    RECRUITING

    Torrance, California, 90503, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Semmes Murphey Foundation - Baptist Memorial Hospital

    NOT_YET_RECRUITING

    Memphis, Tennessee, 38120, United States

  • State University of Iowa

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • State University of New York at Buffalo

    RECRUITING

    Buffalo, New York, 14203, United States

  • UPMC

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33620, United States

  • Valley Baptist Medical Center - Harlingen

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Vanderbilt University Medical Center

    WITHDRAWN

    Nashville, Tennessee, 37232, United States

  • Washington University

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale University

    NOT_YET_RECRUITING

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.