Early treatment for high-risk pulmonary embolism using catheters

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Karl Fengler, MD, Assoc. Prof.
• Email: karl.fengler@medizin.uni-leipzig.de
• Phone: +49 341 865-1426

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-immunogenic staphylokinase (Fortelyzin®) for massive pulmonary embolism

  This project tests whether a single 15 mg bolus of non-immunogenic staphylokinase (Fortelyzin®) is safe and works for adults with massive pulmonary embolism.

  Recruiting at 14 sites Supergene, LLC · Belgorod and 13 other locations · NCT07245927

• Comparing catheter-based treatments for acute pulmonary embolism

  This registry compares outcomes of different catheter-based therapies to see which works best and is safest for people hospitalized with acute pulmonary embolism.

  Recruiting Chinese University of Hong Kong · Hong Kong, Hong Kong · NCT07029841

• Registry of catheter interventions for pulmonary embolism

  This study looks at how safe and effective different catheter treatments are for people with moderate to high-risk pulmonary embolism.

  Recruiting Hospital San Carlos, Madrid · Madrid, Madrid · NCT06348459

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.