Observational Study of Computer-Aided Vacuum Thrombectomy Versus Standard Care in Intermediate and High-Risk Pulmonary Embolism

What this Trial Is About

Pulmonary embolism PE is a serious condition caused by blood clots in the lungs that can lead to death or lower quality of life. This research investigates the use of a newer procedure called computer-aided vacuum thrombectomy CAVT in patients with intermediate to high-risk PE. The study aims to gather more evidence about the safety, effectiveness, and risks of this clot-removal technique, which is currently recommended for very sick patients but lacks data for others who are moderately or severely unwell. The study observes patients who have confirmed intermediate or high-risk PE, some of whom receive thrombectomy using the 16Fr CAVT device to aspirate clots from the pulmonary arteries. This device uses a computer-controlled vacuum to break up and remove clots, potentially offering a faster, lytic-free treatment option. Other patients receive standard care without thrombectomy. The study collects data during hospital treatment and monitors outcomes over time to better understand the benefits and possible complications of thrombectomy compared to conventional management. Participants will be followed with assessments including imaging to measure heart function left ventricle to right ventricle ratio about 48 hours after the procedure. Morbidity and mortality are tracked at multiple time points up to six months. Researchers collect clinical data, patient-reported outcomes, and monitor recovery and quality of life. This observational study is designed to provide detailed information on the safety and longer-term effects of thrombectomy for PE, helping to guide future treatment decisions.

Thrombectomy in Pulmonary Embolism