The Pivotal Study of RapidPulseTM Aspiration System (PIVOTAL)

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: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: RapidPulseTM Aspiration System

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: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Yang; Phone Number: 9498367402; Email: cyang@rapidpulsemed.com

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
    • Not yet 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' Hebrón
    • Contact: Marc Ribo; Email: marcriboj@gmail.com
    • Principal Investigator: Marc Ribó, MD
  • Barcelona, Spain, 08907
    • Recruiting
    • Hospital Universitari de Bellvitge
    • Principal Investigator: Pere Cardona, MD
    • Contact: Pere Cardona, MD; Email: pcardonap@bellvitgehospital.cat
    • 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, 28046
    • Not yet recruiting
    • Hospital Universitario La Paz
    • Principal Investigator: Pedro Navia, MD
  • Madrid, Spain, 28041
    • Not yet recruiting
    • Hospital Universitario 12 de Octubre
    • Principal Investigator: Federico Ballenilla, MD
  • Madrid, Spain, 28006
    • Not yet 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
    • Not yet recruiting
    • Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi
    • Principal Investigator: Arsida Bajrami Geyik, MD
• United States
  • California
    • Torrance, California, United States, 90503
      • Not yet 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
      • Not yet recruiting
      • Baptist Health Research Institute
      • Principal Investigator: Amin Aghaebrahim, MD
    • Tampa, Florida, United States, 33620
      • Not yet 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
      • Not yet 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
      • Recruiting
      • UPMC
      • Principal Investigator: Bradley Gross, MD
  • South Carolina
    • Greenville, South Carolina, United States, 29601
      • Not yet recruiting
      • Prisma Health
      • Principal Investigator: Imran Chaudry, MD
  • 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
      • Not yet recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: Michael Froehler, MD
  • Texas
    • Harlingen, Texas, United States, 78550
      • Not yet recruiting
      • Valley Baptist Medical Center - Harlingen
      • Principal Investigator: Ameer Hassan, DO

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Rate of First Pass Reperfusion Effect (FPE)	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)	The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy	Post-procedural (24 hours post-thrombectomy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of reperfusion after all study device passes	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	Proportion of patients who achieve mRS ≤2 at 90-days post treatment.	Post-procedure (90 days post-thrombectomy)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt	Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass	Intra-procedural
Final reperfusion effect	Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion	Intra-procedural
Time to reperfusion	Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.	Intra-procedural
Rate of major early neurological recovery	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)	All device-related and procedure-related serious adverse events	Intra-procedural to post-procedure (through 90 days post-thrombectomy)
Incidence of all cause mortality	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	Device-related vasospasm	Intra-procedural
Incidence of embolism in new territory	Embolism in new territory determined based on procedural angiogram	Intra-procedural
Incidence of all intracranial hemorrhage	Any intracranial hemorrhage according to the Heidelberg classification at 24-hours	Post-procedural (24 hours post-thrombectomy)

Collaborators and Investigators

• Sponsor: RapidPulse, Inc
• Investigators: Principal Investigator: Raul G Nogueira, MD, University of Pittsburgh Medical Center Stroke Institute; Principal Investigator: Marc Ribó, MD, Hospital Universitari Vall d' Hebrón

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Large Vessel Occlusion; Mechanical Thrombectomy; Neurovascular Intervention
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke; Surgical Procedures, Operative; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Thrombectomy
• Other Study ID 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