RECRUITING

The Pivotal Study of RapidPulseTM Aspiration System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-27
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06029491

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 to 80 years
  2. * Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
  3. * Able to be treated within 8 hours of symptom onset or last known normal (LKN)
  4. * Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
  5. * Pre-morbid Modified Rankin Scale (mRS) score 0-1
  6. * 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
  7. * Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)
  1. * Intracranial Hemorrhage (ICH)
  2. * Alberta Stroke Program Early CT Score (ASPECTS) \<6
  3. * Intracranial Atherosclerotic Disease (ICAD)
  4. * Multiple or tandem occlusions
  5. * Life expectancy less than 6 months

Contacts and Locations

Study Contact

Cynthia Yang
CONTACT
9498367402
cyang@rapidpulsemed.com

Principal Investigator

Raul G Nogueira, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center Stroke Institute
Marc Ribó, MD
PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d' Hebron

Study Locations (Sites)

Providence Saint John's Medical Foundation
Torrance, California, 90503
United States
Yale University
New Haven, Connecticut, 06519
United States
Baptist Health Research Institute
Jacksonville, Florida, 32207
United States
University of South Florida
Tampa, Florida, 33620
United States
Emory University at Grady
Atlanta, Georgia, 30303
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Advocate Aurora Research Institute
Park Ridge, Illinois, 60068
United States
Indiana University Health
Indianapolis, Indiana, 46202
United States
State University of Iowa
Iowa City, Iowa, 52242
United States
Washington University
Saint Louis, Missouri, 63110
United States
Cooper Health System
Camden, New Jersey, 08103
United States
State University of New York at Buffalo
Buffalo, New York, 14203
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
UPMC
Pittsburgh, Pennsylvania, 15213
United States
Prisma Health
Greenville, South Carolina, 29601
United States
Semmes Murphey Foundation - Baptist Memorial Hospital
Memphis, Tennessee, 38120
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Valley Baptist Medical Center - Harlingen
Harlingen, Texas, 78550
United States

Collaborators and Investigators

Sponsor: RapidPulse, Inc

  • Raul G Nogueira, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh Medical Center Stroke Institute
  • Marc Ribó, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-03-27
Study Completion Date2026-12

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Acute Ischemic Stroke