PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RapidPulse, Inc
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- First Pass Reperfusion Effect (FPE)
Study Overview
Brief Summary
A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.
Detailed Description
The purpose of this prospective, open label clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
- •Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
- •Target occlusion can be accessed by the Medtronic React 71 aspiration catheter
Exclusion Criteria
- •Known or suspected intracranial atherosclerotic disease (ICAD)
- •Tandem occlusions
Outcomes
Primary Outcomes
First Pass Reperfusion Effect (FPE)
Time Frame: Intra-procedural
Defined by mTICI greater than or equal to 2c after one reperfusion attempt
Secondary Outcomes
No secondary outcomes reported