Comparing Catheter-Directed Thrombectomy and Systemic Thrombolysis for Treating High-Risk Pulmonary Embolism in Adults

What this Trial Is About

Researchers are evaluating treatments for patients with high-risk pulmonary embolism PE, a serious condition that requires immediate clot removal in addition to blood thinners. This trial compares two approaches catheter-directed thrombectomy CDT, a procedure that directly removes clots using a device, versus standard full-dose systemic thrombolysis, which dissolves clots using medication. The study aims to see if CDT can reduce death rates and serious complications better than the usual treatment, while also improving recovery and quality of life over one year. Participants are randomly assigned to one of two groups. One group receives the CDT procedure, where a catheter is guided through veins to the lungs to extract clots using suction, combined with blood thinners during the procedure. The other group receives full-dose systemic thrombolysis using clot-dissolving drugs such as Alteplase, Urokinase, or Tenecteplase. The study is open-label, meaning both patients and doctors know which treatment is given. Researchers will monitor effects at various points, including day 7, day 30, and up to one year after treatment. During the trial, participants undergo evaluations including clinical and hemodynamic assessments to determine treatment success, monitoring of oxygen levels, length of stay in intensive care and hospital, and quality of life questionnaires over a year. The main measure is a combined rate of death, treatment failure, major bleeding, and stroke at 30 days. Secondary outcomes include survival, bleeding events, oxygen use, and long-term functional recovery. Cost-effectiveness of the treatments will also be analyzed after one year.

'Thrombectomy in High-Risk Pulmonary Embolism - Device Versus Thrombolysis Netherlands': TORPEDO-NL