Randomized Study Comparing Early Catheter-Based Treatment Plus Standard Care Versus Standard Care Alone for High Risk Pulmonary Embolism

What this Trial Is About

Researchers are evaluating treatments for patients with high-risk pulmonary embolism, a serious condition where blood clots block blood flow in the lungs. The trial compares early catheter-directed treatment plus conventional care against conventional care alone. This open-label, multicenter, randomized controlled trial aims to assess which approach better reduces mortality and severe complications within seven days. Participants are randomly assigned to one of two groups. One group receives conventional care following guidelines, including reperfusion treatments, with catheter-based intervention only if no improvement occurs. The other group undergoes catheter-interventional treatment within 60 minutes of randomization, using certified devices such as aspiration thrombectomy and local fibrinolytic therapy, possibly combined with ultrasound assistance. Sheaths used during the catheter procedures are removed shortly after treatment, and fibrinolytic drugs are prepared concurrently to avoid delays if needed. Throughout the study, researchers monitor participants closely, measuring outcomes like death from any cause, recurrent cardiac arrest, and shock within seven days. Secondary outcomes include mortality at 30 days, bleeding events, use of life support devices, heart function changes via echocardiography, ICU stay length, and time to stabilize blood flow. The trial is led by Leipzig Heart Science gGmbH and participants are followed up to assess these key health indicators.

Early Catheter-directed Treatment of High Risk Pulmonary Embolism