Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Medtronic Vascular15 sites in 3 countries109 target enrollmentDecember 3, 2015

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Medtronic Vascular
Enrollment: 109
Locations: 15
Primary Endpoint: Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 3, 2015

End Date

October 21, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Vascular

Responsible Party

Sponsor

Eligibility Criteria

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