PULSE-C: Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke
Study Details
Study Description
Brief Summary
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety 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 target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm 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. |
Device: RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.
Other Names:
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Outcome Measures
Primary Outcome Measures
- First Pass Reperfusion Effect (FPE) [Intra-procedural]
The number of subjects with mTICI ≥ 2c after one reperfusion attempt
Other Outcome Measures
- Frontline technical success [Intra-procedural]
The number of subjects with mTICI ≥ 2b after the last pass with Study Device (no rescue therapy)
- Final mTICI score [Intra-procedural]
The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy)
- Modified First Pass Reperfusion Effect (mFPE) [Intra-procedural]
The number of subjects with mTICI ≥ 2b after one device pass
- Device-related and procedure-related adverse events [Intra and post procedural (up to Day 5-7 or discharge whichever occurs earlier)]
Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours.
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CTA, MRA or DSA demonstrating anterior large vessel occlusion involving the intracranial ICA, MCA M1 or M2 segments, basilar or vertebral artery
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Target occlusion can be accessed by the RapidPulseTM 071 aspiration catheter assessed at the time of the index procedure. Enrollment will be defined by the successful navigation of the RapidPulseTM 071 aspiration catheter into the occlusion site.
Exclusion Criteria:
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Known or suspected ICAD
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Tandem occlusions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institute of Surgery | Tbilisi | Georgia | ||
| 2 | Pineo Medical Ecosystems | Tbilisi | Georgia |
Sponsors and Collaborators
- RapidPulse, Inc
Investigators
- Study Chair: Raul G Nogueira, University of Pittsburgh Medical Center Stroke Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP-0003