Status:
RECRUITING
The Pivotal Study of RapidPulseTM Aspiration System
Lead Sponsor:
RapidPulse, Inc
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06029491
Start Date
March 27 2025
End Date
April 1 2027
Last Update
December 22 2025
Active Locations (30)
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1
Providence Saint John's Medical Foundation
Torrance, California, United States, 90503
2
Yale University
New Haven, Connecticut, United States, 06519
3
Baptist Health Research Institute
Jacksonville, Florida, United States, 32207
4
University of South Florida
Tampa, Florida, United States, 33620