Early treatment for high-risk pulmonary embolism using catheters
A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
This study tests if using a special catheter treatment right away, along with standard care, can help people with severe pulmonary embolism recover better and survive longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leipzig Heart Science gGmbH Academic / other |
| Locations | 18 sites (Bad Krozingen and 17 other locations) |
| Trial ID | NCT06672081 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of early catheter-directed treatment combined with conventional care in patients diagnosed with high-risk pulmonary embolism. It is a prospective, multicenter, open-label, randomized controlled trial that compares outcomes between the intervention group receiving catheter treatment and a control group receiving only conventional care. The study focuses on patients who exhibit signs of severe pulmonary embolism, including cardiac arrest or obstructive shock, and assesses the impact on patient recovery and survival rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with high-risk pulmonary embolism as confirmed by CT angiogram.
Not a fit: Patients with contraindications for catheter-based treatment or systemic fibrinolytic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and recovery outcomes for patients with high-risk pulmonary embolism.
How similar studies have performed: Other studies have shown promising results with catheter-directed treatments for pulmonary embolism, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bad Krozingen and 17 other locations
- 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)
Study contacts
- Study coordinator: Karl Fengler, MD, Assoc. Prof.
- Email: karl.fengler@medizin.uni-leipzig.de
- Phone: +49 341 865-1426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.