Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

544

Participants

Timeline

Start Date

August 2, 2021

Primary Completion Date

July 31, 2025

Study Completion Date

August 31, 2026

Conditions
Pulmonary Embolism
Interventions
DRUG

Anticoagulation with heparin

Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)

DEVICE

EkoSonicTM Endovascular System

EkoSonicTM Endovascular System \[ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg\]

Trial Locations (63)

10029

Mount Sinai Medical Center, New York

10032

Columbia University Medical Center, New York

10075

Lenox Hill Hospital, New York

19718

Christiana Hospital, Newark

21201

University of Maryland School of Medicine, Baltimore

22908

University of Virginia Medical Center, Charlottesville

30309

Piedmont Hospital, Atlanta

30322

Emory University Hospital, Atlanta

30904

Augusta University, Augusta

35294

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

37660

Wellmont Holston Valley Medical Center, Kingsport

38801

North Mississippi Medical Center, Tupelo

40202

Jewish Hospital, Louisville

40207

Baptist Health East Louisville, Lousville

44106

University Hospitals of Cleveland, Cleveland

45429

Kettering Health, Kettering

46410

Methodist Hospitals, Merrillville

48109

University of Michigan Hospitals, Ann Arbor

48202

Henry Ford Hospital, Detroit

53792

University of Wisconsin Hospitals, Madison

60515

Advocate Good Samaritan Hospital, Downers Grove

68114

Nebraska Methodist Hospital, Omaha

75093

The Heart Hospital Baylor Plano, Plano

77479

Houston Methodist Sugarland Hospital, Houston

78705

Seton Medical Center, Austin

90048

Cedars - Sinai Medical Center, Los Angeles

02114

Massachusetts General Hospital, Boston

03756

Dartmouth-Hitchcock Medical Center, Lebanon

08103

Cooper Hospital - University Medical Center, Camden

07112

Newark Beth Israel Medical Center, Newark

Unknown

A.o. LKH Univ.-Kliniken Innsbruck, Innsbruck

Universitätsklinikum St. Pölten, Sankt Pölten

Allgemeines Krankenhaus AKH, Vienna

Austria Klinik Ottakring Vienna, Vienna

CHU de Besancon, Besançon

CHU (Nimes Cedex), Nîmes

Hôpital Européen Georges Pompidou (HEGP), Paris

Uniklinik Aachen, Aachen

Klinikum Bielefeld, Bielefeld

GFO Kliniken Bonn, Bonn

Klinikum Chemnitz, Chemnitz

Universitaetsklinikum Freiburg, Freiburg im Breisgau

Klinik Immenstadt, Immenstädt

Universitaetsklinikum Schleswig-Holstein, Lübeck

Johannes Gutenberg Universitaet Mainz, Mainz

Klinikum Rechts der Isar, Munich

Universitaetsklinikum Tuebingen, Tübingen

Universitaetsklinikum Wuerzburg, Würzburg

Mater Misericordiae University Hospital, Dublin

University Hospital Galway, Galway

Leiden University Medical Center, Leiden

St. Antonius Ziekenhuis, Nieuwegein

Universitair Medisch Centrum, Utrecht

John Paul II Hospital, Krakow

Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan

Medical University of Warsaw, Warsaw

University Hospital Basel, Basel

Centre Hospitalier Universitaire Vaudois, Lausanne

University Hospital Zurich, Zurich

University Hospital of Wales, Cardiff

The Royal Free Hospital, London

Northwick Park Hospital, Middlesex

Sponsors
All Listed Sponsors
collaborator

National PERT Consortium, Inc.

UNKNOWN

collaborator

University Medical Center Mainz

OTHER

lead

Boston Scientific Corporation

INDUSTRY