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Acute Ischemic StrokeTURBONCT06029491

Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions

A study testing RapidPulseTM Aspiration System in people with Acute Ischemic Stroke, run by RapidPulse, Inc at 30 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
RapidPulseTM Aspiration System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
30 sitesin 4 countries
Study dates
27 Mar 2025to Sep 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 85 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)

Who cannot join

  • Intracranial Hemorrhage (ICH)
  • Significant mass effect and/or midline shift
  • Alberta Stroke Program Early CT Score (ASPECTS) <6 or (PC-ASPECTS <8 on CT angiography source images or DWI MRI for posterior circulation stroke)
  • Intracranial Atherosclerotic Disease (ICAD)
  • Multiple or tandem occlusions
  • Life expectancy less than 6 months

Trial locations and contacts

30 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Cynthia Yang contact

9498367402

cyang@rapidpulsemed.com

30 sites in 4 countries

United States18 sites, 15 recruiting

  • Emory University at Grady

    Atlanta, Georgia, 30303

    Jonathan Grossberg, MD

    Recruiting

  • State University of New York at Buffalo

    Buffalo, New York, 14203

    Jason Davies, MD

    Recruiting

  • Cooper Health System

    Camden, New Jersey, 08103

    Jane Khalife, MD

    Not yet recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Michael Chen, MD

    Recruiting

  • Prisma Health

    Greenville, South Carolina, 29601

    Withdrawn

  • Valley Baptist Medical Center - Harlingen

    Harlingen, Texas, 78550

    Ameer Hassan, DO

    Recruiting

  • Indiana University Health

    Indianapolis, Indiana, 46202

    Bradley Bohnstedt, MD

    Not yet recruiting

  • State University of Iowa

    Iowa City, Iowa, 52242

    Edgar Samaniego, MD

    Recruiting

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207

    Amin Aghaebrahim, MD

    Recruiting

  • Semmes Murphey Foundation - Baptist Memorial Hospital

    Memphis, Tennessee, 38120

    Nitin Goyal, MD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

    Withdrawn

  • Yale University

    New Haven, Connecticut, 06519

    Charles Matouk, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Tomoyoshi Shigematsu, MD

    Recruiting

  • Advocate Aurora Research Institute

    Park Ridge, Illinois, 60068

    Michael Young, MD

    Recruiting

  • UPMC

    Pittsburgh, Pennsylvania, 15213

    Active, not recruiting

  • Washington University

    St Louis, Missouri, 63110

    Arindam Chatterjee, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33620

    Maxim Mokin, MD

    Recruiting

  • Providence Saint John's Medical Foundation

    Torrance, California, 90503

    Jason Tarpley, MD

    Recruiting

Other trials in United States

Spain8 sites, 8 recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    José Ignacio Gallego, MD

    Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

    Sebastià Remollo, MD

    Sebastià Remollo, MD

    Recruiting

  • Hospital Universitari Vall d' Hebron

    Barcelona, 08035

    Marc Ribo, marcriboj@gmail.com

    Marc Ribó, MD

    Recruiting

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

    Pere Cardona, MD, pcardonap@bellvitgehospital.cat

    Pere Cardona, MD

    Recruiting

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

    Mikel Terceno Izaga, MD

    Not yet recruiting

  • Hospital Universitario de la Princesa

    Madrid, 28006

    María del Carmen Ramos Martín, MD

    José Luis Caniego, MD

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Federico Ballenilla, MD

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Pedro Navia, MD

    Recruiting

Other trials in Spain

France3 sites, 3 recruiting

  • Centre Hospitalier Universitaire de Bordeaux

    Bordeaux, 33000

    Gaultier Marnat, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295

    Vincent Costalat, MD

    Not yet recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse, 31059

    Christophe Cognard, MD

    Not yet recruiting

Other trials in France

Turkey (Türkiye)1 site, 1 recruiting

  • Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi

    Istanbul, 34295

    Arsida Bajrami Geyik, MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions (TURBO)

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.

Read the detailed description

The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 40 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who achieve modified treatment in cerebral infarction score (mTICI) ≥ 2b, based on the best mTICI score within a maximum of 3 passes where only aspiration with the Study Device was used without rescue, as assessed by an independent Imaging Core Lab. The primary safety endpoint is the proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy as assessed by an independent central events committee (CEC).

Being tested
RapidPulseTM Aspiration System
Keywords
Stroke, Large Vessel Occlusion, Mechanical Thrombectomy, Neurovascular Intervention
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RapidPulseTM Aspiration SystemDevice

    Also called Aspiration Thrombectomy, Thrombectomy

    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 groups in NCT06029491
Study groupRoleWhat they receive
Treatment ArmExperimentalEach 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.
Receives: Device: RapidPulseTM Aspiration System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of perfusion success using only the study device.

    The proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes where only aspiration with the Study Device was used without rescue, as assessed by an independent Imaging Core Lab.

    Measured: Intra-procedural

  2. Rate of symptomatic intracranial hemorrhage (sICH)

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

    Measured: Post-procedural (24 hours post-thrombectomy)

Secondary outcomes (1)

  1. Modified Rankin Scale (mRS) at 90 days post treatment

    Proportion of patients who achieve mRS ≤2 at 90-days post treatment.

    Measured: Post-procedure (90 days post-thrombectomy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start27 Mar 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06029491
Sponsor's protocol ID
CIP-0002
Acronym
TURBO
Status last verified
Oct 2026
First submitted
1 Sep 2023
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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