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Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke

NCT05899036 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-01-22

No results posted yet for this study

Summary

The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).

Conditions

  • Acute Ischemic Stroke
  • Stroke
  • Large Vessel Occlusion
  • Mechanical Thrombectomy

Interventions

DEVICE

RapidPulseTM Aspiration System

The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.

Sponsors & Collaborators

  • RapidPulse, Inc

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-23
Primary Completion
2024-10-22
Completion
2024-10-27

Countries

  • Paraguay
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

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 NCT05899036 on ClinicalTrials.gov