The Pivotal Study of RapidPulseTM Aspiration System (PIVOTAL)

June 30, 2026 updated by: RapidPulse, Inc

The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 30 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 First Pass Reperfusion Effect (FPE) as defined by modified treatment in cerebral infarction score (mTICI) ≥ 2c after the first pass 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 a central events committee (CEC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Not yet recruiting
        • Centre hospitalier universitaire de Bordeaux
        • Principal Investigator:
          • Gaultier Marnat, MD
      • Montpellier, France, 34295
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Montpellier
        • Principal Investigator:
          • Vincent Costalat, MD
      • Toulouse, France, 31059
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Toulouse
        • Principal Investigator:
          • Christophe Cognard, MD
  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario Dr. Balmis
        • Principal Investigator:
          • José Ignacio Gallego, MD
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:
          • Sebastià Remollo, MD
        • Principal Investigator:
          • Sebastià Remollo, MD
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d' Hebron
        • Contact:
        • Principal Investigator:
          • Marc Ribó, MD
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Principal Investigator:
          • Pere Cardona, MD
        • Contact:
        • Principal Investigator:
          • Oscar Chirife, MD
      • Girona, Spain, 17007
        • Not yet recruiting
        • Hospital Universitari de Girona Dr. Josep Trueta
        • Principal Investigator:
          • Mikel Terceno Izaga, MD
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Principal Investigator:
          • Federico Ballenilla, MD
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Principal Investigator:
          • Pedro Navia, MD
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa
        • Principal Investigator:
          • María del Carmen Ramos Martín, MD
        • Principal Investigator:
          • José Luis Caniego, MD
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34295
        • Recruiting
        • Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi
        • Principal Investigator:
          • Arsida Bajrami Geyik, MD
  • United States
    • California
      • Torrance, California, United States, 90503
        • Recruiting
        • Providence Saint John's Medical Foundation
        • Principal Investigator:
          • Jason Tarpley, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Not yet recruiting
        • Yale University
        • Principal Investigator:
          • Charles Matouk, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist Health Research Institute
        • Principal Investigator:
          • Amin Aghaebrahim, MD
      • Tampa, Florida, United States, 33620
        • Recruiting
        • University of South Florida
        • Principal Investigator:
          • Maxim Mokin, MD
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University at Grady
        • Principal Investigator:
          • Jonathan Grossberg, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • Michael Chen, MD
      • Park Ridge, Illinois, United States, 60068
        • Not yet recruiting
        • Advocate Aurora Research Institute
        • Principal Investigator:
          • Michael Young, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Not yet recruiting
        • Indiana University Health
        • Principal Investigator:
          • Bradley Bohnstedt, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • State University of Iowa
        • Principal Investigator:
          • Edgar Samaniego, MD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University
        • Principal Investigator:
          • Arindam Chatterjee, MD
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Not yet recruiting
        • Cooper Health System
        • Principal Investigator:
          • Jane Khalife, MD
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • State University of New York at Buffalo
        • Principal Investigator:
          • Jason Davies, MD
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School Of Medicine At Mount Sinai
        • Principal Investigator:
          • Tomoyoshi Shigematsu, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Active, not recruiting
        • UPMC
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Withdrawn
        • Prisma Health
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Not yet recruiting
        • Semmes Murphey Foundation - Baptist Memorial Hospital
        • Principal Investigator:
          • Nitin Goyal, MD
      • Nashville, Tennessee, United States, 37232
        • Withdrawn
        • Vanderbilt University Medical Center
    • Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Valley Baptist Medical Center - Harlingen
        • Principal Investigator:
          • Ameer Hassan, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: 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.
Other Names:
  • Thrombectomy
  • Aspiration Thrombectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of First Pass Reperfusion Effect (FPE)
Time Frame: Intra-procedural
The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass
Intra-procedural
Rate of symptomatic intracranial hemorrhage (sICH)
Time Frame: Post-procedural (24 hours post-thrombectomy)
The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy
Post-procedural (24 hours post-thrombectomy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of reperfusion after all study device passes
Time Frame: Intra-procedural
Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device
Intra-procedural
Modified Rankin Scale (mRS) at 90 days post treatment
Time Frame: Post-procedure (90 days post-thrombectomy)
Proportion of patients who achieve mRS ≤2 at 90-days post treatment.
Post-procedure (90 days post-thrombectomy)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt
Time Frame: Intra-procedural
Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass
Intra-procedural
Final reperfusion effect
Time Frame: Intra-procedural
Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion
Intra-procedural
Time to reperfusion
Time Frame: Intra-procedural
Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.
Intra-procedural
Rate of major early neurological recovery
Time Frame: Post-procedure (24 hours post-thrombectomy)

Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of at least 8 points or reaching NIHSS 0-1.

*NIHSS ranges from 0 to 42, with higher scores indicating greater neurological deficit.
Post-procedure (24 hours post-thrombectomy)
Incidence of Serious Adverse Events (SAEs)
Time Frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
All device-related and procedure-related serious adverse events
Intra-procedural to post-procedure (through 90 days post-thrombectomy)
Incidence of all cause mortality
Time Frame: Intra-procedural to post-procedure (through 90 days post-thrombectomy)
All-cause mortality assessed through 90 days post index procedure.
Intra-procedural to post-procedure (through 90 days post-thrombectomy)
Incidence of device related vasospasm
Time Frame: Intra-procedural
Device-related vasospasm
Intra-procedural
Incidence of embolism in new territory
Time Frame: Intra-procedural
Embolism in new territory determined based on procedural angiogram
Intra-procedural
Incidence of all intracranial hemorrhage
Time Frame: Post-procedural (24 hours post-thrombectomy)
Any intracranial hemorrhage according to the Heidelberg classification at 24-hours
Post-procedural (24 hours post-thrombectomy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RapidPulse, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raul G Nogueira, MD, University of Pittsburgh Medical Center Stroke Institute
  • Principal Investigator: Marc Ribó, MD, Hospital Universitari Vall d' Hebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 27, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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