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

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions

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).

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: RapidPulseTM Aspiration System; Device: Standard of Care Aspiration Thrombectomy System

Detailed Description

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
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Fortaleza, Brazil
    • General Hospital of Fortaleza
• Denmark
  • Odense, Denmark
    • Odense University Hospital
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• Spain
  • Alicante, Spain
    • Hospital General Universitari d'Alicante
• Turkey
  • Istanbul, Turkey
    • Istanbul Aydin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.	Device: RapidPulseTM Aspiration System; The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Other: Control Arm; Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.	Device: Standard of Care Aspiration Thrombectomy System; Commercially available aspiration catheter with commercially available aspiration pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Pass Reperfusion Effect (FPE)	Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel	Intra-procedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontline technical success	Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy	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)	90 days
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure		24 hours
All cause mortality rate		90 days

Collaborators and Investigators

• Sponsor: RapidPulse, Inc
• Investigators: Study Chair: Raul G Nogueira, MD, University of Pittsburgh Medical Center Stroke Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 12, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Large vessel occlusion; Mechanical thrombectomy; Neurovascular intervention
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: DEV-0213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No