A Prospective, Multicenter Study of the Indigo Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

This is a post-market study of the medical device called the Indigo™ Aspiration System. This device is used for the treatment of a blocked blood vessel in the lungs, or in medical terms Pulmonary embolism (PE). It removes the clot by sucking the clot out of the body. This is otherwise called aspiration thrombectomy. This study will be looking to evaluate the safety and performance of the Indigo™ Aspiration System in a real-life setting and collect information on how patients recover after the treatment. All physicians will follow routine site practice guidelines to determine patient eligibility for PE treatment. No study-specific screening tests or procedures will be required for enrollment in the study. Potential study participants ? 18 years of age who present with acute PE will be identified by the study team at the participating site. The Investigator will obtain written informed consent using the current approved consent form. The treatment will be undertaken after the completion of baseline assessments and pre-procedural imaging of the heart called Echocardiogram. The participants enrolled in the study will receive standard pre- and post-procedural care for patients who have undergone mechanical thrombectomy for acute PE. After the discharge, the participants will return to 90-Day and 365-Day Follow-up visits. With the exception of study-specific health questionnaires (PEmb-QoL and EQ-5D-5L), a 6-minute walk test (6MWT) and a post-procedure Echocardiogram, the rest of the assessments will be completed as per standard hospital practice.The study allows for the enrollment of approximately 600 subjects at up to 55 sites globally.The results of this study will provide additional data on safety and patient-centric functional outcomes of the use of the Indigo™ Aspiration System.