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RapidPulseTM Aspiration System for Acute Ischemic Stroke

This study is testing the RapidPulseTM Aspiration System, a device designed to remove blood clots from the brain in people who have had an acute ischemic stroke. The system uses precisely pulsed suction to clear the blocked blood vessels. The goal is to see how safe and effective the RapidPulseTM Aspiration System is when used within 8 hours of stroke symptoms starting. You may be able to join if you are 18-80 years old, have had a recent acute ischemic stroke, and have a good level of health before the stroke. The study will measure how well the device clears the clot and if there are any serious bleeding complications in the brain. The current recruitment status is unclear.

Study design
This is an open-label study, meaning both you and your doctors will know you are receiving the RapidPulseTM Aspiration System. The study plans to enroll 170 participants globally.
What's involved
You would undergo a mechanical thrombectomy procedure using the RapidPulseTM Aspiration System. You will have follow-up assessments at 24 hours, 5-7 days (or at hospital discharge), and a final visit around 90 days after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 90 days after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06029491

The Pivotal Study of RapidPulseTM Aspiration System

Recruiting
NAAges 18–80InterventionalTreatment
RapidPulse, Inc
~170 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:RapidPulseTM Aspiration System

At a glance

Recruiting sites
15 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of First Pass Reperfusion Effect (FPE)
Measured over Intra-procedural
+1 more outcome measured

Conditions

Acute Ischemic Stroke

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Acute Ischemic StrokeLarge Vessel Occlusion

NCT06029491

Where you'd take part

This study runs at 30 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hospital Universitari de Bellvitge

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Advocate Aurora Research Institute

    Park Ridge, Illinoisno site contact published

    Not yet recruiting

  • Baptist Health Research Institute

    Jacksonville, Floridano site contact published

    Recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, Franceno site contact published

    Not yet recruiting

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, Franceno site contact published

    Not yet recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, Franceno site contact published

    Not yet recruiting

  • Cooper Health System

    Camden, New Jerseyno site contact published

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Raul G Nogueira, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh Medical Center Stroke Institute
  • Marc Ribó, MD · PRINCIPAL_INVESTIGATOR · Hospital Universitari Vall d' Hebron

Who to contact

Cynthia Yang
[email protected]
9498367402
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rate of First Pass Reperfusion Effect (FPE)Intra-procedural

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

  • Rate of symptomatic intracranial hemorrhage (sICH)Post-procedural (24 hours post-thrombectomy)

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