Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment polymer-free des (drug eluting stent)
Sponsor Medtronic Vascular
Start date June 2015
End date September 2016
Trial size 100 participants
Trial identifier NCT02480348, V2 04Mar2015

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
polymer-free des (drug eluting stent)

Primary Outcomes

Measure
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medtronic Vascular.