Recruiting

RapidPulseTM Aspiration

Sponsor:

RapidPulse, Inc

Code:

NCT06029491

Conditions

Acute Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RapidPulseTM Aspiration System

Study Details

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

Study ID

NCT06029491

Start date

Mar 27, 2025

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Rate of First Pass Reperfusion Effect (FPE) [ Time Frame: Intra-procedural ]
  • Rate of symptomatic intracranial hemorrhage (sICH) [ Time Frame: Post-procedural (24 hours post-thrombectomy) ]

Central Contacts and Locations

Central contacts

Cynthia Yang

9498367402cyang@rapidpulsemed.com

Locations

Providence Saint John's Medical Foundation

Recruiting

Torrance, California, United States, 90503

Principal Investigator:

Jason Tarpley, MD

Baptist Health Research Institute

Recruiting

Jacksonville, Florida, United States, 32207

Principal Investigator:

Amin Aghaebrahim, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33620

Principal Investigator:

Maxim Mokin, MD

Emory University at Grady

Recruiting

Atlanta, Georgia, United States, 30303

Principal Investigator:

Jonathan Grossberg, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Michael Chen, MD

State University of New York at Buffalo

Recruiting

Buffalo, New York, United States, 14203

Principal Investigator:

Jason Davies, MD

Valley Baptist Medical Center - Harlingen

Recruiting

Harlingen, Texas, United States, 78550

Principal Investigator:

Ameer Hassan, DO

More Information

Sponsor

RapidPulse, Inc

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Stroke
  • Large Vessel Occlusion
  • Mechanical Thrombectomy
  • Neurovascular Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RapidPulse, Inc on 2026-07-02.