The Pivotal Study of RapidPulseTM Aspiration System
- Conditions
- Acute Ischemic Stroke
- Interventions
- Device: RapidPulseTM Aspiration System
- Registration Number
- NCT06029491
- Lead Sponsor
- RapidPulse, Inc
- Brief 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. 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Arm RapidPulseTM Aspiration System 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.
- Primary Outcome Measures
Name Time Method Rate of First Pass Reperfusion Effect (FPE) Intra-procedural The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass
Rate of symptomatic intracranial hemorrhage (sICH) Post-procedural (24 hours post-thrombectomy) The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy
- Secondary Outcome Measures
Name Time Method Rate of reperfusion after all study device passes Intra-procedural Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device
Modified Rankin Scale (mRS) at 90 days post treatment Post-procedure (90 days post-thrombectomy) Proportion of patients who achieve mRS ≤2 at 90-days post treatment.
Trial Locations
- Locations (30)
Providence Saint John's Medical Foundation
🇺🇸Torrance, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Baptist Health Research Institute
🇺🇸Jacksonville, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Emory University at Grady
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
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
🇺🇸Saint Louis, Missouri, United States
Cooper Health System
🇺🇸Camden, New Jersey, United States
State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Prisma Health
🇺🇸Greenville, South Carolina, United States
Semmes Murphey Foundation - Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Valley Baptist Medical Center - Harlingen
🇺🇸Harlingen, Texas, United States
Centre Hospitalier Universitaire de Bordeaux
🇫🇷Bordeaux, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier, France
Centre Hospitalier Universitaire de Toulouse
🇫🇷Toulouse, France
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Spain
Hospital Universitari Vall d' Hebron
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Istanbul Aydan Universitesi VM Medical Park Florya Hastanesi
🇹🇷Istanbul, Turkey