Observational Study of Symphony and Prodigy Thrombectomy Systems
This study is looking at how well the Symphony and Prodigy Thrombectomy Systems work and how safe they are. These systems are medical devices used to remove blood clots (thrombi/emboli) from blood vessels in your arms, legs, or lungs. The study aims to understand their performance in people with arterial thromboembolism, venous thromboembolism, or pulmonary embolism. Researchers will follow 750 participants to see the short-term and long-term results. You might be able to join if you are 18 or older, willing to follow the study schedule, and are having a procedure that uses one of these devices. The study is currently unclear about its recruitment status.
- Study design
- This is an observational study involving 750 participants. It is designed to evaluate the performance and safety of medical devices.
- What's involved
- You would need to be willing and able to comply with the follow-up schedule specified in the protocol. You would also need to provide written informed consent before any study-related data is collected.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 30 days to measure the primary outcomes related to their condition.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Aspiration Thrombectomy Using the Symphony or Prodigy System
At a glance
Conditions
Where it's being run
8 sites across 7 statesStudy leadership
- Steven Abramowitz, MD · PRINCIPAL_INVESTIGATOR · Medstar Health Research Institute
- Maya Serhal, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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What this trial measures
- Peripheral Arterial Cohort30 days
Freedom from major (above-ankle) unanticipated amputation of the index limb
- Peripheral Venous Cohort30 days
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
- Pulmonary Embolism (PE) Cohort30 Days
Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) \>1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.