Early Catheter-directed Treatment of High Risk Pulmonary Embolism
Recruiting now · Not applicable
Conditions studied: Pulmonary Embolism Acute Massive
In brief
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
Key facts
- Study ID
- NCT06672081
- Run by
- Leipzig Heart Science gGmbH
- People needed
- 210
- Starts
- 2024-12-27
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:
- a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP <90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
- Age ≥18 years
You may not qualify if…
- Contraindications for catheter-based treatment
- Contraindications to systemic fibrinolytic treatment or anticoagulation*
- Active, potentially life-threatening bleeding
- Surgery within 24h before screening
- Cranial or spinal surgery within 14d before screening
- Stroke within 14d before screening
- Intracranial tumor
- Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
- Pregnancy
- Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
Where it is running
- Universitätsklinikum Freiburg — Bad Krozingen, Germany (enrolling)
- Oberlausitzklinikum Bautzen, Medizinische Klinik I — Bautzen, Germany (enrolling)
- Universitätsklinikum Bonn — Bonn, Germany (enrolling)
- Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie — Düsseldorf, Germany (enrolling)
- HELIOS Klinikum Erfurt — Erfurt, Germany (enrolling)
- Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie — Frankfurt am Main, Germany (enrolling)
- Universitätsklinikum Halle — Halle, Germany (enrolling)
- Asklepios Klinik St. Georg — Hamburg, Germany (enrolling)
- SLK-Kliniken Heilbronn — Heilbronn, Germany (enrolling)
- Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2 — Kaiserslautern, Germany (enrolling)
- Universitätsklinikum Leipzig — Leipzig, Germany (enrolling)
- Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology — Leipzig, Germany (enrolling)
- Universitätsklinikum Mannheim — Mannheim, Germany (enrolling)
- Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd — Nuremberg, Germany (enrolling)
- Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie — Ulm, Germany (enrolling)
- Schwarzwald-Baar-Klinikum — Villingen-Schwenningen, Germany (enrolling)
- Rems-Murr-Kliniken — Winnenden, Germany (enrolling)
- Helios Kliniken Wuppertal — Wuppertal, Germany (enrolling)
Full record on ClinicalTrials.gov
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