XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
Launched by ABBOTT MEDICAL DEVICES · May 12, 2008
Trial Information
Current as of July 08, 2025
Completed
Keywords
ClinConnect Summary
Study Phase I is from index procedure to 1 year. This prospective, open-label, multi-center, observational, single-arm study is designed to evaluate XIENCE V EECSS safety and effectiveness in real world settings up to 1 year after implantation. The primary endpoint is the stent thrombosis (definite and probable) rate up to 1 year as ARC. The co-primary endpoint is the composite rate of cardiac death and any MI at 1 year. Up to 8,000 patients are planned to be consecutively enrolled at up to 275 sites in the U.S. Clinical follow-up will occur at 14, 30, 180 days and 1 year.
All patients enr...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.
- Exclusion Criteria:
- • The inability to obtain an informed consent.
- • Age limit is determined by investigator.
- • There are no angiographic inclusion or exclusion criteria for this study.
About Abbott Medical Devices
Abbott Medical Devices is a leading global healthcare company dedicated to advancing medical technology through innovative research and development. With a robust portfolio of diagnostic, therapeutic, and monitoring solutions, Abbott is committed to improving patient outcomes and enhancing the quality of care across various medical fields. The company places a strong emphasis on clinical trials to validate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals. By leveraging cutting-edge science and technology, Abbott Medical Devices aims to address pressing health challenges and deliver transformative solutions that empower patients and healthcare providers alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Santa Clara, California, United States
Patients applied
Trial Officials
James Hermiller, MD
Principal Investigator
Heart Center of Indianapolis
Mitch Krucoff, MD
Principal Investigator
Duke University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials