Status:

RECRUITING

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Lead Sponsor:

Leipzig Heart Science gGmbH

Collaborating Sponsors:

Heart Center Leipzig at University of Leipzig

Helios Health Institute GmbH

Conditions:

Pulmonary Embolism Acute Massive

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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...

Eligibility Criteria

Inclusion Criteria:

  1. 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

  2. Age ≥18 years

Exclusion Criteria:

  1. Contraindications for catheter-based treatment

  2. Contraindications to systemic fibrinolytic treatment or anticoagulation*

    1. Active, potentially life-threatening bleeding
    2. Surgery within 24h before screening
    3. Cranial or spinal surgery within 14d before screening
    4. Stroke within 14d before screening
    5. Intracranial tumor
    6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
  3. Pregnancy

    • Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.

Key Trial Info

Start Date :

December 27 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

210 Patients enrolled

Trial Details

Trial ID

NCT06672081

Start Date

December 27 2024

End Date

June 30 2027

Last Update

March 4 2026

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Universitätsklinikum Freiburg

Bad Krozingen, Germany, 79189

2

Oberlausitzklinikum Bautzen, Medizinische Klinik I

Bautzen, Germany, 02625

3

Universitätsklinikum Bonn

Bonn, Germany, 53127

4

Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie

Düsseldorf, Germany, 40225

Early Catheter-directed Treatment of High Risk Pulmonary Embolism | DecenTrialz