The Pivotal Study of RapidPulseTM Aspiration System as Frontline Approach for Patient With Acute Ischemic Stroke Due to Large Vessel Occlusions
RapidPulse, Inc
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.
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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 I…
Interventions
- DeviceRapidPulseTM 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.
Locations (30)
- Providence Saint John's Medical FoundationTorrance, California
- Yale UniversityNew Haven, Connecticut
- Baptist Health Research InstituteJacksonville, Florida
- University of South FloridaTampa, Florida
- Emory University at GradyAtlanta, Georgia
- Rush University Medical CenterChicago, Illinois