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

NCT ID: NCT05577351

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-23
• Study Completion Date: 2023-06-13

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

RapidPulseTM Aspiration System

Intervention Type: DEVICE

The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System

Interventions

RapidPulseTM Aspiration System

The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System

Intervention Type: DEVICE

Other Intervention Names

Aspiration Thrombectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RapidPulse, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raul G Nogueira, MD

Role: STUDY_CHAIR

University of Pittsburgh Medical Center Stroke Institute

Locations

National Institute of Surgery

Tbilisi, , Georgia

Pineo Medical Ecosystems

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

CIP-0004

Identifier Type: -

Identifier Source: org_study_id