The Pivotal Study of RapidPulseTM Aspiration System

Part of paid clinical trials in Torrance, California.

Sponsor
RapidPulse, Inc
Study ID
NCT06029491
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 27, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Rate of First Pass Reperfusion Effect (FPE) [ Time Frame: Intra-procedural ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
Providence Saint John's Medical FoundationTorranceCalifornia90503
Jason Tarpley, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06519
Charles Matouk, MD (PRINCIPAL_INVESTIGATOR)
Baptist Health Research InstituteJacksonvilleFlorida32207
Amin Aghaebrahim, MD (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33620
Maxim Mokin, MD (PRINCIPAL_INVESTIGATOR)
Emory University at GradyAtlantaGeorgia30303
Jonathan Grossberg, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Michael Chen, MD (PRINCIPAL_INVESTIGATOR)
Advocate Aurora Research InstitutePark RidgeIllinois60068
Michael Young, MD (PRINCIPAL_INVESTIGATOR)
Indiana University HealthIndianapolisIndiana46202
Bradley Bohnstedt, MD (PRINCIPAL_INVESTIGATOR)
State University of IowaIowa CityIowa52242
Edgar Samaniego, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Arindam Chatterjee, MD (PRINCIPAL_INVESTIGATOR)
Cooper Health SystemCamdenNew Jersey08103
Jane Khalife, MD (PRINCIPAL_INVESTIGATOR)
State University of New York at BuffaloBuffaloNew York14203
Jason Davies, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Tomoyoshi Shigematsu, MD (PRINCIPAL_INVESTIGATOR)
UPMCPittsburghPennsylvania15213
Bradley Gross, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29601
Imran Chaudry, MD (PRINCIPAL_INVESTIGATOR)
Semmes Murphey Foundation - Baptist Memorial HospitalMemphisTennessee38120
Nitin Goyal, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Michael Froehler, MD (PRINCIPAL_INVESTIGATOR)
Valley Baptist Medical Center - HarlingenHarlingenTexas78550
Ameer Hassan, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Torrance, CA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Providence Saint John's Medical Foundation· Torrance, CAYale University· New Haven, CTBaptist Health Research Institute· Jacksonville, FLUniversity of South Florida· Tampa, FLEmory University at Grady· Atlanta, GARush University Medical Center· Chicago, IL

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