Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Last updated: March 3, 2026
Sponsor: Leipzig Heart Science gGmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Circulation Disorders

Cardiovascular Disease

Treatment

Early Catheter-Interventional Treatment

Conventional care

Clinical Study ID

NCT06672081
2024-0124
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as definedby ESC guidelines: a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP <90mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate fillingstatus), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria orserum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction ontransthoracic echocardiogram or CT scan

  2. Age ≥18 years

Exclusion

Exclusion Criteria:

  1. Contraindications for catheter-based treatment

  2. Contraindications to systemic fibrinolytic treatment or anticoagulation*

  3. Active, potentially life-threatening bleeding

  4. Surgery within 24h before screening

  5. Cranial or spinal surgery within 14d before screening

  6. Stroke within 14d before screening

  7. Intracranial tumor

  8. Any condition not listed here but estimated as clinically relevant as judged bythe treating investigator

  9. Pregnancy

  • Patients with contraindications to systemic fibrinolysis or anticoagulation canbe enrolled in a third study arm (registry) and undergo catheter-directedtherapy.

Study Design

Total Participants: 210
Treatment Group(s): 2
Primary Treatment: Early Catheter-Interventional Treatment
Phase:
Study Start date:
December 27, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Universitätsklinikum Freiburg

    Bad Krozingen, 79189
    Germany

    Active - Recruiting

  • Oberlausitzklinikum Bautzen, Medizinische Klinik I

    Bautzen, 02625
    Germany

    Active - Recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127
    Germany

    Active - Recruiting

  • Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • HELIOS Klinikum Erfurt

    Erfurt, 99089
    Germany

    Active - Recruiting

  • Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie

    Frankfurt am Main, 60590
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle

    Halle, 06120
    Germany

    Active - Recruiting

  • Universitätsklinikum Halle

    Halle (Saale), 06120
    Germany

    Site Not Available

  • Asklepios Klinik St. Georg

    Hamburg, 20099
    Germany

    Active - Recruiting

  • SLK-Kliniken Heilbronn

    Heilbronn, 74078
    Germany

    Active - Recruiting

  • Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2

    Kaiserslautern, 67655
    Germany

    Active - Recruiting

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

    Leipzig, 04289
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitätsklinikum Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

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

    Nuremberg, 90471
    Germany

    Active - Recruiting

  • Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie

    Ulm, 89081
    Germany

    Active - Recruiting

  • Schwarzwald-Baar-Klinikum

    Villingen-Schwenningen, 78052
    Germany

    Active - Recruiting

  • Rems-Murr-Kliniken

    Winnenden, 71364
    Germany

    Active - Recruiting

  • Helios Kliniken Wuppertal

    Wuppertal, 42117
    Germany

    Active - Recruiting

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