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

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: RapidPulseTM Aspiration System; Device: Standard of Care Aspiration Thrombectomy System

• Registration Number: NCT05122637
• Lead Sponsor: RapidPulse, Inc

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-12
• Study First Posted: 2021-11-17
• Study Start: 2022-01-31
• Primary Completion: 2022-09-23
• Study Completion: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-28
• Last Update Posted: 2023-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	RapidPulseTM Aspiration System	RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.
Control Arm	Standard of Care Aspiration Thrombectomy System	Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Istanbul Aydin University; 🇹🇷 Istanbul, Turkey

Hospital General Universitari d'Alicante; 🇪🇸 Alicante, Spain

Pauls Stradiņš Clinical University Hospital; 🇱🇻 Riga, Latvia

Odense University Hospital; 🇩🇰 Odense, Denmark

General Hospital of Fortaleza; 🇧🇷 Fortaleza, Brazil