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

NCT05122637 | Completed DMC

• 1 other identifier: DEV-0213
• Study Type: interventional
• Target: 80
• Locations: 5 countries
• Sites: 5

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).

Conditions

Acute Ischemic Stroke

Keywords

Large vessel occlusion; Mechanical thrombectomy; Neurovascular intervention

Outcome Measures

Primary Outcomes (1)

• First Pass Reperfusion Effect (FPE)

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

  Intra-procedural

Secondary Outcomes (4)

• Frontline technical success

  Intra-procedural

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

  90 days

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

  24 hours

• All cause mortality rate

  90 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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

Control Arm

OTHER

Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.

Device: Standard of Care Aspiration Thrombectomy System

Interventions

RapidPulseTM Aspiration System DEVICE

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

Treatment Arm

Standard of Care Aspiration Thrombectomy System DEVICE

Commercially available aspiration catheter with commercially available aspiration pump

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RapidPulse, Inc: lead

Study Sites (5)

General Hospital of Fortaleza

Fortaleza, Brazil

Location

Odense University Hospital

Odense, Denmark

Location

Pauls Stradiņš Clinical University Hospital

Riga, Latvia

Location

Hospital General Universitari d'Alicante

Alicante, Spain

Location

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raul G Nogueira, MD

  University of Pittsburgh Medical Center Stroke Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 17, 2021
• Study Start: January 31, 2022
• Primary Completion: September 23, 2022
• Study Completion: December 20, 2022
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); ES (1); TU (1); LA (1); DK (1)