Medtronic RevElution Trial
This trial is active, not recruiting.
|Condition||coronary artery disease|
|Treatment||polymer-free des (drug eluting stent)|
|Start date||June 2015|
|End date||September 2016|
|Trial size||100 participants|
|Trial identifier||NCT02480348, V2 04Mar2015|
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|
|Sydney, Australia||Eastern Heart Clinic - Prince of Wales Hospital||no longer recruiting|
|Chermside, Australia||The Prince Charles Hospital||no longer recruiting|
|Adelaide, Australia||St. Andrew's Hospital||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Auchenflower, Australia||Wesley Hospital / HeartCare Partners||no longer recruiting|
|Bedford Park, Australia||Flinders Medical Center||no longer recruiting|
|Melbourne, Australia||Monash Medical Center||no longer recruiting|
|Melbourne, Australia||Northern Hospital||no longer recruiting|
|New Castle, Australia||John Hunter Hospital||no longer recruiting|
|NSW, Australia||St. Vincent's Hospital||no longer recruiting|
|NSW, Australia||Royal North Shore Hospital||no longer recruiting|
|Perth WA, Australia||Fiona Stanley Hospital||no longer recruiting|
|QLD, Australia||Royal Brisbane & Women's Hospital||no longer recruiting|
|São Paulo, Brazil||Institute Dante Pazzanese of Cardiology||no longer recruiting|
|Singapore, Singapore||National Heart Center Singapore||no longer recruiting|
|Intervention model||single group assignment|
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
time frame: 9 months
All 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
|Official title||Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions|
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