RecruitingNot ApplicableNCT06433011

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

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


Sponsor

Thrombolex, Inc.

Enrollment

500 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called The Bashir™ Endovascular Catheter and a drug called r-tPA for people with pulmonary embolism. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEThe 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.

DRUGr-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

View Full Details on ClinicalTrials.gov

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NCT06433011


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