The Pivotal Study of RapidPulseTM Aspiration System
The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
RapidPulse, Inc
170 participants
Mar 27, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria5
- 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
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Interventions
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.
Locations(30)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06029491