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RECRUITING
NCT06433011
NA

The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism

Sponsor: Thrombolex, Inc.

View on ClinicalTrials.gov

Summary

To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).

Official title: The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-10-17

Completion Date

2028-04-25

Last Updated

2026-07-14

Healthy Volunteers

No

Interventions

DEVICE

The Bashir™ Endovascular Catheter

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

DRUG

r-tPA

Pulse spray and infusion

Locations (23)

Honor Health

Scottsdale, Arizona, United States

Carondelet St. Joseph's Hospital

Tuscon, Arizona, United States

Radiology and Imaging Specialists

Lakeland, Florida, United States

Emory University

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Profound Research

Hobart, Indiana, United States

Community Health

Indianapolis, Indiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Dartmouth Hitchcock

Lebanon, New Hampshire, United States

Cooper Health

Camden, New Jersey, United States

St. Joseph's

Liverpool, New York, United States

Northwell Health

Manhasset, New York, United States

Mount Sinai

New York, New York, United States

TriHealth

Cincinnati, Ohio, United States

Miami Valley/Wright State University/Premier Health

Dayton, Ohio, United States

Jobst Vascular Institute - ProMedica Hospital

Toledo, Ohio, United States

Temple University

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Sentara

Norfolk, Virginia, United States

Charleston Area Medical Center

Charleston, West Virginia, United States