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

RapidPulse, Inc5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

RapidPulseTM Aspiration SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

National Institute of Surgery

Tbilisi, Georgia

Pineo Medical Ecosystems

Tbilisi, Georgia

Outcomes

Primary Outcomes

First Pass Reperfusion Effect (FPE)

Defined by mTICI greater than or equal to 2c after one reperfusion attempt

Time frame: Intra-procedural

Data from ClinicalTrials.gov

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