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

PHASE3CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

June 23, 2020

Primary Completion Date

June 22, 2022

Study Completion Date

June 23, 2022

Conditions
Pulmonary Embolism
Interventions
DEVICE

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.

DRUG

r-tPA

Pulse spray and infusion

Trial Locations (19)

10016

NYU Langone, New York

13088

St. Joseph's Hospital, Liverpool

15232

UPMC Heart and Vascular Institute, Pittsburgh

16550

UPMC Hamot, Erie

19122

Temple University Hospital, Philadelphia

25304

CAMC, Charleston

27607

NC Heart, Raleigh

30308

Emory, Atlanta

30309

Piedmont Heart Institute, Atlanta

32803

Advent Health Orlando, Orlando

33176

Miami Cardiac & Vascular Institute, Miami

37934

Tennova Heart - Turkey Creek, Knoxville

43213

Mt Carmel, Columbus

46260

Ascension St. Vincent, Indianapolis

48073

Beaumont Hospital, Royal Oak, Royal Oak

48201

Ascension St. John Hospital, Detroit

55455

University of Minnesota, Minneapolis

60521

Loyola University Chicago, Maywood

90095

UCLA, Los Angeles

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Thrombolex, Inc.

INDUSTRY

NCT04248868 - tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden | Biotech Hunter | Biotech Hunter