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

NCT04248868 | Completed Phase 3 Results DMC FDA Drug FDA Device

• 1 other identifier: THRO-CLIN-2019-01
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Catheter Directed Therapy

Outcome Measures

Primary Outcomes (2)

• Efficacy: RV/LV Ratio Difference

  Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).

  48 hours after the completion of r-tPA treatment

• Safety: Major Bleeding

  Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.

  Within 72 hours of initiation of r-tPA administration

Study Arms (1)

BEC Treatment

EXPERIMENTAL

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

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

Interventions

The Bashir™ Endovascular Catheter DEVICE

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

BEC Treatment

r-tPA DRUG

Pulse spray and infusion

BEC Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• 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;
• 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;

Sponsors & Collaborators

• Thrombolex, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (19)

UCLA

Los Angeles, California, 90095, United States

Location

Miami Cardiac & Vascular Institute

Miami, Florida, 33176, United States

Location

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

Emory

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Loyola University Chicago

Maywood, Illinois, 60521, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46260, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48201, United States

Location

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St. Joseph's Hospital

Liverpool, New York, 13088, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

NC Heart

Raleigh, North Carolina, 27607, United States

Location

Mt Carmel

Columbus, Ohio, 43213, United States

Location

UPMC Hamot

Erie, Pennsylvania, 16550, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19122, United States

Location

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15232, United States

Location

Tennova Heart - Turkey Creek

Knoxville, Tennessee, 37934, United States

Location

CAMC

Charleston, West Virginia, 25304, United States

Location

Related Publications (1)

• Bashir R, Foster M, Iskander A, Darki A, Jaber W, Rali PM, Lakhter V, Gandhi R, Klein A, Bhatheja R, Ross C, Natarajan K, Nanjundappa A, Angle JF, Ouriel K, Amoroso NE, Firth BG, Comerota AJ, Piazza G, Rosenfield K, Sista AK. Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2427-2436. doi: 10.1016/j.jcin.2022.09.011. Epub 2022 Sep 17.

  PMID: 36121244 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Christopher A. Schultz
• Organization: Eminence Clinical Research, Inc.

cschultz@ecr-inc.com

9715067552

Study Officials

• Brian Firth, MD, PhD, MBA, FACC

  Thrombolex, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Pulse Spray and Infusion of r-tPA

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: June 23, 2020
• Primary Completion: June 22, 2022
• Study Completion: June 23, 2022
• Last Updated: April 20, 2023
• Results First Posted: April 20, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)