The Pivotal Study of RapidPulseTM Aspiration System
Recruiting now · Not applicable
Conditions studied: Acute Ischemic Stroke
In brief
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 facts
- Study ID
- NCT06029491
- Run by
- RapidPulse, Inc
- People needed
- 170
- Starts
- 2025-03-27
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-07-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Providence Saint John's Medical Foundation — Torrance, California, United States (enrolling)
- Baptist Health Research Institute — Jacksonville, Florida, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Emory University at Grady — Atlanta, Georgia, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- State University of New York at Buffalo — Buffalo, New York, United States (enrolling)
- Valley Baptist Medical Center - Harlingen — Harlingen, Texas, United States (enrolling)
- Hospital General Universitario Dr. Balmis — Alicante, Spain (enrolling)
- Hospital Universitari Germans Trias i Pujol — Badalona, Spain (enrolling)
- Hospital Universitari Vall d' Hebron — Barcelona, Spain (enrolling)
- Hospital Universitari de Bellvitge — Barcelona, Spain (enrolling)
- Hospital Universitario de la Princesa — Madrid, Spain (enrolling)
- Hospital Universitario 12 de Octubre — Madrid, Spain (enrolling)
- Hospital Universitario La Paz — Madrid, Spain (enrolling)
- Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi — Istanbul, Turkey (Türkiye) (enrolling)
- Semmes Murphey Foundation - Baptist Memorial Hospital — Memphis, Tennessee, United States
- Yale University — New Haven, Connecticut, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
- Hospital Universitari de Girona Dr. Josep Trueta — Girona, Spain
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France
- Advocate Aurora Research Institute — Park Ridge, Illinois, United States
- Indiana University Health — Indianapolis, Indiana, United States
- State University of Iowa — Iowa City, Iowa, United States
- Washington University — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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