A Single-Arm Study to Assess the Safety and Efficacy of the SoundBiteTM Crossing System with ACTIVE Wire in Coronary Chronic Total Occlusions. (The ACTIVE Trial)
The ACTIVE Trial: Study of SoundBiteTM in Coronary Chronic Total Occlusions
Sponsor: SoundBite Medical Solutions, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAS1070
U.S. Govt. ID: NCT03521804
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: This is a prospective, multi-center, single-arm, phased clinical study intended to provide pivotal data for device approval. The study is intended to demonstrate that the device, the SoundBite Crossing System Coronary can allow the passage of devices intended to treat a Chronic total occlusion (CTO). When arteries that supply blood to the heart become completely blocked, they are referred to as Chronic total occlusion (CTO). Although most blockages in the heart vessels can be opened by interventional cardiologists using minimally invasive techniques, opening completely blocked vessels remains a challenge. Successful opening of occluded coronary arteries (heart vessels) has been strongly associated with increased survival, heart muscle function, and freedom from angina and bypass surgery. Approximately 154 patients are expected to participate in this study, in 10 sites across Canada and the USA. The duration of the study is 30 days (+/- 7 days) from the date of your procedure. A required follow-up visit will be scheduled to complete some tests which may include Physical Exam, blood test and vital signs.
This study is closed
Investigator
Ajay Kirtane, MD, SM
Do You Qualify?
Are you 18 years of age or older? Yes No
Submit
Cancel
You may be eligible for this study

Place Holder




For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366