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Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Sponsor: Leipzig Heart Science gGmbH
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
Conditions
Interventions
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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
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