Coronary Artery Disease
Conditions
Brief summary
The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
Interventions
DEVICEPolymer-free DES (Drug Eluting Stent)
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery * Must have evidence of ischemic heart disease * Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent * Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
Exclusion criteria
* Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative * History of a stroke or transient ischemic attack (TIA) within the prior 6 months * Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months * History of bleeding diathesis or coagulopathy or will refuse blood transfusions * Concurrent medical condition with a life expectancy of less than 5 years * Currently participating in an investigational drug or another device trial that has not completed the primary endpoint * Documented left ventricular ejection fraction (LVEF) \< 30% at the most recent evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography. | 9 months |
Countries
Australia, Brazil, Singapore
Outcome results
None listed