Early Catheter-directed Treatment of High Risk Pulmonary Embolism

NCT06672081 · tracked via the Priya Life Science Germany tracker

Sponsor

Leipzig Heart Science gGmbH

Phase

Not applicable

Started

2024-12-27

Last updated

2026-03-04

Condition(s) studied

Pulmonary Embolism Acute Massive

Investigational drug(s) / intervention(s)

Early Catheter-Interventional TreatmentConventional care

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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.

Conventional care: reperfusion treatment

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Composite endpoint of mortality (all-cause) and recurrent cardiac arrest or persistent / recurrent shock — 7 days
1. mortality (all-cause) up to 7 days after randomization and 2. either one of the following 1. recurrent cardiac arrest or 2. persistent / recurrent shock (systolic BP \<90 mmHg or vasopressors or ECMO required to achieve a systolic BP ≥90 mmHg, in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) 24 hours after randomization

Trial sites (18)

Facility	City	Region	Status
Universitätsklinikum Freiburg	Bad Krozingen	Germany	Recruiting
Oberlausitzklinikum Bautzen, Medizinische Klinik I	Bautzen	Germany	Recruiting
Universitätsklinikum Bonn	Bonn	Germany	Recruiting
Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf	Germany	Recruiting
HELIOS Klinikum Erfurt	Erfurt	Germany	Recruiting
Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie	Frankfurt am Main	Germany	Recruiting
Universitätsklinikum Halle	Halle	Germany	Recruiting
Asklepios Klinik St. Georg	Hamburg	Germany	Recruiting
SLK-Kliniken Heilbronn	Heilbronn	Germany	Recruiting
Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2	Kaiserslautern	Germany	Recruiting
Universitätsklinikum Leipzig	Leipzig	Germany	Recruiting
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology	Leipzig	Germany	Recruiting
Universitätsklinikum Mannheim	Mannheim	Germany	Recruiting
Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd	Nuremberg	Germany	Recruiting
Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie	Ulm	Germany	Recruiting
Schwarzwald-Baar-Klinikum	Villingen-Schwenningen	Germany	Recruiting
Rems-Murr-Kliniken	Winnenden	Germany	Recruiting
Helios Kliniken Wuppertal	Wuppertal	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06672081 on ClinicalTrials.gov ↗ ← All trials in Germany