Early Catheter-directed Treatment of High Risk Pulmonary Embolism

NARecruitingINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

December 27, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Pulmonary Embolism Acute Massive
Interventions
PROCEDURE

Early Catheter-Interventional Treatment

Patients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.

DRUG

Conventional care

reperfusion treatment

Trial Locations (11)

20099

RECRUITING

Asklepios Klinik St. Georg, Hamburg

42117

RECRUITING

Helios Kliniken Wuppertal, Wuppertal

53127

RECRUITING

Universitätsklinikum Bonn, Bonn

68167

RECRUITING

Universitätsklinikum Mannheim, Mannheim

71364

RECRUITING

Rems-Murr-Kliniken, Winnenden

74078

RECRUITING

SLK-Kliniken Heilbronn, Heilbronn

78052

RECRUITING

Schwarzwald-Baar-Klinikum, Villingen-Schwenningen

79189

RECRUITING

Universitätsklinikum Freiburg, Bad Krozingen

06120

RECRUITING

Universitätsklinikum Halle, Halle

04103

RECRUITING

Universitätsklinikum Leipzig, Leipzig

04289

RECRUITING

Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology, Leipzig

All Listed Sponsors
collaborator

Heart Center Leipzig at University of Leipzig

UNKNOWN

collaborator

Helios Health Institute GmbH

OTHER

lead

Leipzig Heart Science gGmbH

OTHER