NCT06672081

Early Catheter-directed Treatment of High Risk Pulmonary Embolism

A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Leipzig Heart Science gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pulmonary Embolism Acute Massive

Interventions

Type	Name	Description
PROCEDURE	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 Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.
DRUG	Conventional care	reperfusion treatment

Timeline

• Start date: 2024-12-27
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-11-04
• Last updated: 2026-03-04

Locations

18 sites across 1 country: Germany