Long-Term Evaluation of the Indigo Aspiration System for Pulmonary Embolism Treatment Safety and Functional Outcomes Study

What this Trial Is About

Researchers are evaluating the long-term safety, performance, and functional outcomes of the Indigo Aspiration System for treating pulmonary embolism PE. This observational study focuses on patients with acute PE and aims to gather real-world data on how well the device works and its safety over time. Participants receive frontline treatment with the Indigo Aspiration System as part of their standard care for acute PE. The study monitors patients for safety events within 48 hours after the procedure and assesses heart function by measuring the right ventricle to left ventricle ratio. Quality of life and functional outcomes are evaluated at 90 days, along with longer-term monitoring for serious device-related events and mortality up to one year and 30 days respectively. During the study, participants will undergo diagnostic imaging and clinical assessments to track their recovery and the effects of the device. Researchers will collect data on adverse events, quality of life questionnaires, exercise capacity tests, and symptom scales. The total participation lasts up to several months, including follow-up visits to ensure comprehensive monitoring of safety and function after treatment.

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System