tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden

Completed · Phase 3

Conditions studied: Pulmonary Embolism

In brief

To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.

Key facts

Study ID

NCT04248868

Run by

Thrombolex, Inc.

People needed

109

Starts

2020-06-23

Expected to finish

2022-06-23

Last updated by the study team

2023-04-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing and able to provide informed consent;
• Age 18 to ≤ 75 years of age;
• PE symptom duration ≤ 14 days.
• Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
• RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
• Willing and able to comply with all study procedures and follow-up.

You may not qualify if…

• CVA or TIA within one (1) year;
• Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
• Active bleeding from a major organ within one (1) month prior to inclusion in the study;
• Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
• Patients with bleeding diatheses;
• Hematocrit < 30%;
• Platelets < 100,000/μL;
• INR > 1.5 if currently on warfarin (Coumadin®);
• aPTT > 50 seconds in the absence of anticoagulants;
• Major surgery ≤ 14 days prior to inclusion in the study;
• Serum creatinine > 2.0mg/dL;
• Clinician deems high-risk for catastrophic bleeding;
• History of heparin-induced thrombocytopenia (HIT Syndrome);
• Pregnancy;
• SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
• Any vasopressor support;
• Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
• Evidence of irreversible neurological compromise;
• Life expectancy < one (1) year;
• Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
• Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) within 48 hours prior to inclusion in the study;
• Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
• Previous enrollment in this study;
• Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
• BMI > 45kg/m2;

Where it is running

• UCLA — Los Angeles, California, United States
• Miami Cardiac & Vascular Institute — Miami, Florida, United States
• Advent Health Orlando — Orlando, Florida, United States
• Emory — Atlanta, Georgia, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Ascension St. Vincent — Indianapolis, Indiana, United States
• Ascension St. John Hospital — Detroit, Michigan, United States
• Beaumont Hospital, Royal Oak — Royal Oak, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• St. Joseph's Hospital — Liverpool, New York, United States
• NYU Langone — New York, New York, United States
• NC Heart — Raleigh, North Carolina, United States
• Mt Carmel — Columbus, Ohio, United States
• UPMC Hamot — Erie, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• UPMC Heart and Vascular Institute — Pittsburgh, Pennsylvania, United States
• Tennova Heart - Turkey Creek — Knoxville, Tennessee, United States
• CAMC — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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