An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II) (NEVO II)
Atherosclerotic Coronary Artery Disease
About this trial
This is an interventional treatment trial for Atherosclerotic Coronary Artery Disease focused on measuring Coronary artery disease, Drug-eluting stents, Reservoir technology
Eligibility Criteria
Inclusion Criteria:
- Subject has atherosclerotic coronary artery disease with an indication for stent implantation;
- Target lesion(s) with a diameter stenosis of minimally 50% (visual estimate) OR a functional study documenting the hemodynamic relevance of the target lesion(s);
- All target lesion(s) require treatment with stents having diameters from 2.5mm to 3.5mm (visual estimate);
- Subject is ≥18 years of age;
- Subject must sign Ethics Committee approved informed consent prior to undergoing any study specific procedure;
- Subject must be willing and able to comply with specified follow-up schedule.
Exclusion Criteria:
- Planned medical procedures or concomitant disease requiring modification of DAPT regimen within 6 months of enrollment into this study;
- Women of childbearing potential without negative pregnancy test within 7 days before enrollment OR women who do not agree to remain on birth control until angiographic follow-up at 13 months if applicable OR lactating women. For women of childbearing potential, requiring an acute, non-elective procedure, a verbal confirmation of non-pregnancy and birth control is sufficient;
- Currently participating in an investigational study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Sites / Locations
- Erasmus MC - Thoraxcenter
- Hospital Universitari Clinic de Barcelona
- Inselspital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NEVO™ SES
XIENCE V®/XIENCE PRIME™/PROMUS®
Design Protocol Am3.0 - safety follow-up: The study population consists of 103 subjects with atherosclerotic coronary artery disease treated with the NEVO™ SES. Candidates for the initial NEVO II Study must have met ALL inclusion criteria and NO exclusion criteria. Design Original Protocol Subjects randomized to treatment with the NEVO™ Sirolimus-eluting Coronary Stent System.
Subjects randomized to treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System