Protocol Description
The purpose of this study is to evaluate the continued safety and effectiveness of the XIENCE™ V Everolimus Eluting Coronary Stent System (the XIENCE™ V EECSS) recently approved for use by the U.S. Food and Drug Administration (FDA) for the treatment of narrowed coronary arteries (blood vessels in the heart) in a group of real-world patients. Up to 8,000 patients are to be consecutively enrolled at up to 275 sites in the United States of America (U.S.). This study consists of two study phases.
- Phase I: Index procedure to 1 year (standard of care).
- Phase II: A prospective, multi-center, randomized, double-blind Abbott Vascular- Dual Antiplatelet Therapy (AV-DAPT) cohort to assess the effectiveness and safety of 12 versus 30 months of DAPT in patients undergoing percutaneous coronary intervention (PCI) with XIENCE V placement for the treatment of coronary artery lesions.
Eligibility Criteria
You may qualify for this registry study if:
- you agree to participate in this study by signing the IRB approved informed consent form.
- have received a Xience V EECSS stent(s) during index procedure.
Primary Investigator(s)
Christopher Cannon, MD
Contact Information
Dawn Bowles, RN, CCRP
540-224-4658
or
Diana Talmadge, RN
540-981-7493
for mail
for deliveries