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

RapidPulse, Inc80 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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

RapidPulseTM Aspiration SystemDEVICE

The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.

Standard of Care Aspiration Thrombectomy SystemDEVICE

Commercially available aspiration catheter with commercially available aspiration pump

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

General Hospital of Fortaleza

Fortaleza, Brazil

Odense University Hospital

Odense, Denmark

Pauls Stradiņš Clinical University Hospital

Riga, Latvia

Hospital General Universitari d'Alicante

Alicante, Spain

Outcomes

Primary Outcomes

First Pass Reperfusion Effect (FPE)

Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel

Time frame: Intra-procedural

Secondary Outcomes

Frontline technical success

Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy

Time frame: Intra-procedural

Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure

The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)

Time frame: 90 days

Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure

Time frame: 24 hours

All cause mortality rate

Time frame: 90 days

Data from ClinicalTrials.gov

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