Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke (PULSE-F)

RapidPulse

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Device: RapidPulseTM Aspiration System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05577351

CIP-0004

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) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Treatment Arm

Experimental group

Description:

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 thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.

Treatment:

Device: RapidPulseTM Aspiration System