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NCT06433011NARecruiting

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

Thrombolex, Inc.

Start Date

10/17/2024

Completion Date

4/25/2028

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).

Detailed Description

The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

The Bashir™ Endovascular Catheter

DRUG

r-tPA

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Conditions

Pulmonary Embolism

Locations

Honor Health

Scottsdale, Arizona 85258

United States

Carondelet St. Joseph's Hospital

Tuscon, Arizona 85711

United States

Radiology and Imaging Specialists

Lakeland, Florida 33801

United States

Emory University

Atlanta, Georgia 30308

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

Profound Research

Hobart, Indiana 46342

United States

Community Health

Indianapolis, Indiana 46256

United States

Boston Medical Center

Boston, Massachusetts 02135

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02481

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts 01805

United States

North Mississippi Medical Center

Tupelo, Mississippi 38801

United States

Dartmouth Hitchcock

Lebanon, New Hampshire 03756

United States

Cooper Health

Camden, New Jersey 08103

United States

St. Joseph's

Liverpool, New York 13088

United States

Northwell Health

Manhasset, New York 11030

United States

Mount Sinai

New York, New York 10029

United States

TriHealth

Cincinnati, Ohio 45242

United States

Miami Valley/Wright State University/Premier Health

Dayton, Ohio 45435

United States

Jobst Vascular Institute - ProMedica Hospital

Toledo, Ohio 43606

United States

Temple University

Philadelphia, Pennsylvania 19140

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Sentara

Norfolk, Virginia 23507

United States

Charleston Area Medical Center

Charleston, West Virginia 25304

United States