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:
-
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
Exclusion Criteria:
-
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.
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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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