StudyFinder

Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the redUction of thrombus burdEn - The RESCUE Study

Completed

RESCUE is a prospective, non-randomized, multicenter study of the Bashir™ Endovascular Catheter (BEC), a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The study objective is 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.

I'm interested

All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• 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.
Exclusion Criteria:

• 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;
• Absolute contraindication to anticoagulation;
• Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
• Currently participating in another study;
• Any arterial line placement;
• Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or > 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
• In the opinion of the investigator, the subject is not a suitable candidate for the study.

Device: The Bashir™ Endovascular Catheter, Drug: r-tPA

Pulmonary Embolism

Pulmonary Embolism, Catheter Directed Therapy

Jill Novitzke - novit001@umn.edu
Michael Rosenberg
Phase 3
STUDY00010186
NCT04248868
See this study on ClinicalTrials.gov

Back