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RECRUITING
NCT06672081
NA

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Sponsor: Leipzig Heart Science gGmbH

View on ClinicalTrials.gov

Summary

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism

Official title: A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2024-12-27

Completion Date

2027-06-30

Last Updated

2026-03-04

Healthy Volunteers

No

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.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

Locations (18)

Universitätsklinikum Freiburg

Bad Krozingen, Germany

Oberlausitzklinikum Bautzen, Medizinische Klinik I

Bautzen, Germany

Universitätsklinikum Bonn

Bonn, Germany

Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie

Düsseldorf, Germany

HELIOS Klinikum Erfurt

Erfurt, Germany

Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie

Frankfurt am Main, Germany

Universitätsklinikum Halle

Halle, Germany

Asklepios Klinik St. Georg

Hamburg, Germany

SLK-Kliniken Heilbronn

Heilbronn, Germany

Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2

Kaiserslautern, Germany

Universitätsklinikum Leipzig

Leipzig, Germany

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

Leipzig, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd

Nuremberg, Germany

Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie

Ulm, Germany

Schwarzwald-Baar-Klinikum

Villingen-Schwenningen, Germany

Rems-Murr-Kliniken

Winnenden, Germany

Helios Kliniken Wuppertal

Wuppertal, Germany