Early catheter treatment compared with usual care for high-risk pulmonary embolism
Compares early catheter treatment plus usual care with usual care in high-risk pulmonary embolism.
Key facts
- Who runs it
- Leipzig Heart Science gGmbH
- Where
- Germany18 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Early Catheter-directed Treatment of High Risk Pulmonary Embolism
- Status
- Recruiting
- People taking part
- 210 people, planned
- Started
- 27 Dec 2024
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Early Catheter-Interventional Treatment
- Conventional care
- Record updated
- 4 March 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a high-risk pulmonary embolism (a blood clot in the lungs) confirmed by CT angiogram. It compares early catheter treatment plus usual care with usual care alone.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- High-risk pulmonary embolism under ESC guidelines. This means cardiac arrest, or shock with systolic BP <90 mmHg or a need for vasopressors (drugs that raise blood pressure) to keep BP ≥90 mmHg. The shock must come with signs of poor blood flow to organs (cold, clammy skin, little urine or serum lactate ≥2 mmol/L). The heart's right side must also show signs of strain on echocardiogram or CT scan.
Main reasons for not taking part
- Reasons you cannot have catheter-based treatment
- Active bleeding that could be life-threatening
- Surgery within 24h, or brain or spine surgery within 14d, before screening
- Stroke within 14d before screening, or a tumor inside the skull
- Pregnancy
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:; 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
Who cannot take part
- Pregnancy; Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy
- 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
- Contraindications for catheter-based treatment
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- conventional careExisting treatment, for comparison
Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines
- Early Catheter-Interventional Treatment + conventional careTreatment being tested
Patients in this group 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. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.
Treatment: Early Catheter-Interventional Treatment and Conventional care
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism
- Plain-language title
- Early catheter treatment compared with usual care for high-risk pulmonary embolismGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 4 March 2026