RecruitingNot ApplicableNCT06672081

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

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

Sponsor

Leipzig Heart Science gGmbH

Enrollment

210 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Embolism Acute Massive

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Conventional care and a procedure called Early Catheter-Interventional Treatment for people with pulmonary embolism acute massive. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.

DRUGConventional 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

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NCT06672081

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