BIOTRONIK - A Prospective Multicenter Study to Confirm the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions - VII
Sponsor: |
BIOTRONIK, Inc |
Enrolling: |
Male and Female Patients |
Study Length: |
5 Years |
IRB Number: |
AAAS8457 |
U.S. Govt. ID: |
NCT04175626 |
Contact: |
Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
This is a prospective, multi-center, single-arm study aimed at finding out if the clinical performance of a device called the Orsiro stent, in a real-world setting is similar to the clinical performance observed for the device in the BIOFLOW-V IDE pivotal trial. After receiving the Orsiro stent, you will be followed through 5 years of follow-up, with assessments performed at 1 month, 1 year and annually thereafter. All visits will be performed by telephone interview, unless a standard of care routine office visit is planned within the applicable follow-up window.
This study is closed
Investigator
Michael Collins, MD
Are you at least 18 years old? |
Yes |
No |