Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.

Official Title
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Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: RapidPulseTM Aspiration System
* Device: Standard of Care Aspiration Thrombectomy System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Age 18 years or older Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery Key Exclusion Criteria: Evidence of hemorrhage Significant mass effect and/or midline shift Vessel tortuosity too difficult to allow endovascular access per investigator judgment Severe or fatal co-morbidities

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique. | Device: RapidPulseTM Aspiration System<br>* The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.<br>|
| Other: Control Arm<br>Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique. | Device: Standard of Care Aspiration Thrombectomy System<br>* Commercially available aspiration catheter with commercially available aspiration pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Pass Reperfusion Effect (FPE) | Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel | Intra-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frontline technical success | Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy | Intra-procedural | 
| Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure | The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased) | 90 days | 
| Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure |  | 24 hours | 
| All cause mortality rate |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Large vessel occlusion, Mechanical thrombectomy, Neurovascular intervention