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

NCT05122637 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-03-02

No results posted yet for this study

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

Interventions

DEVICE

RapidPulseTM Aspiration System

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

DEVICE

Standard of Care Aspiration Thrombectomy System

Commercially available aspiration catheter with commercially available aspiration pump

Sponsors & Collaborators

  • RapidPulse, Inc

    lead INDUSTRY

Principal Investigators

  • Raul G Nogueira, MD · University of Pittsburgh Medical Center Stroke Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-09-23
Completion
2022-12-20

Countries

  • Brazil
  • Denmark
  • Latvia
  • Spain
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05122637 on ClinicalTrials.gov