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

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Device: RapidPulseTM Aspiration System

• Registration Number: NCT05577351
• 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) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-09
• Study First Posted: 2022-10-13
• Study Start: 2023-04-23
• Primary Completion: 2023-06-03
• Study Completion: 2023-06-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	RapidPulseTM Aspiration System	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.

Primary Outcome Measures

Name	Time	Method
First Pass Reperfusion Effect (FPE)	Intra-procedural	Defined by mTICI greater than or equal to 2c after one reperfusion attempt

Trial Locations

Locations (2)

National Institute of Surgery; 🇬🇪 Tbilisi, Georgia

Pineo Medical Ecosystems; 🇬🇪 Tbilisi, Georgia