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

This study is enrolling patients who have or have had a pulmonary embolism (PE). A PE is a blood clot in an artery or arteries in the lung. A clot can be life threatening if immediate action is not taken to resolve it. One possible treatment for PE is to remove the clot using a medical device that sucks the clot out of the patient’s body. This is called aspiration thrombectomy. The device that will be used for aspiration thrombectomy in this study is the Indigo™ Aspiration System.
The purpose of this study is to collect information on how patients with PE recover after treatment with the Indigo Aspiration System.
The Indigo Aspiration System is a medical device that has been cleared by the U.S. Food and Drug Administration (FDA) for removing blood clots from the blood vessels throughout the body, excluding the head. The device is commercially available globally.