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

RapidPulse

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: Standard of Care Aspiration Thrombectomy System; Device: RapidPulseTM Aspiration System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05122637

DEV-0213

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.

Treatment:

Device: RapidPulseTM Aspiration System

Control Arm

Other group

Description:

Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.

Treatment:

Device: Standard of Care Aspiration Thrombectomy System