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Clinical Trials in the USA / NCT06433011
Recruiting Not applicable

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

NCT06433011 · tracked via the Priya Life Science USA tracker
Sponsor
Thrombolex, Inc.
Phase
Not applicable
Started
2024-10-17
Last updated
2026-07-14

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

The Bashir™ Endovascular Catheterr-tPA

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.

r-tPA: Pulse spray and infusion

Study 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

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria 1. Willing and able to provide informed consent; 2. PE symptom duration ≤ 15 days; 3. Filling defect in at least one major lobar pulmonary artery as determined by CTA; 4. Patient is diagnosed with intermediate risk PE; 5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site; 6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit. Exclusion Criteria: 1. Previous history of stroke with residual hemiplegia; 2. Major surgery ≤ 10 days prior to inclusion in the study; 3. Platelet count \< 100,000/μL; 4. Pulmonary thrombectomy within the previous 4 days; 5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure; 6. Administration of thrombolytic agents within the previous 4 days; 7. Absolute contraindication to anticoagulation; 8. Clinician deems high-risk for catastrophic bleeding; 9. Pregnancy; 10. Any vasopressor or inotropic support; 11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution; 12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays; 13. Currently participating in another study; 14. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
Honor Health Scottsdale Arizona Recruiting
Carondelet St. Joseph's Hospital Tuscon Arizona Recruiting
Radiology and Imaging Specialists Lakeland Florida Recruiting
Emory University Atlanta Georgia Recruiting
Rush University Medical Center Chicago Illinois Recruiting
Profound Research Hobart Indiana Recruiting
Community Health Indianapolis Indiana Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Lahey Hospital & Medical Center Burlington Massachusetts Recruiting
North Mississippi Medical Center Tupelo Mississippi Recruiting
Dartmouth Hitchcock Lebanon New Hampshire Recruiting
Cooper Health Camden New Jersey Recruiting
St. Joseph's Liverpool New York Recruiting
Northwell Health Manhasset New York Recruiting
Mount Sinai New York New York Recruiting
TriHealth Cincinnati Ohio Recruiting
Miami Valley/Wright State University/Premier Health Dayton Ohio Recruiting
Jobst Vascular Institute - ProMedica Hospital Toledo Ohio Recruiting
Temple University Philadelphia Pennsylvania Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Sentara Norfolk Virginia Recruiting
Charleston Area Medical Center Charleston West Virginia Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06433011 on ClinicalTrials.gov ↗ ← All trials in the USA