Clinical trial NCT02480348: Medtronic RevElution Trial
Official title: Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Eastern Heart Clinic - Prince of Wales Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: St. Andrew's Hospital
state: South Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Auchenflower
country: Australia
facility: Wesley Hospital / HeartCare Partners
city: Bedford Park
country: Australia
facility: Flinders Medical Center
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
city: Melbourne
country: Australia
facility: Monash Medical Center
city: Melbourne
country: Australia
facility: Northern Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: New Lambton
country: Australia
facility: John Hunter Hospital
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
city: São Paulo
country: Brazil
facility: Institute Dante Pazzanese of Cardiology
city: Singapore
country: Singapore
facility: National Heart Center Singapore
Study officials:
References:
citation: Worthley SG, Abizaid A, Kirtane AJ, Simon DI, Windecker S, Brar S, Meredith IT, Shetty S, Sinhal A, Almonacid AP, Chamie D, Maehara A, Stone GW; RevElution Investigators. First-in-Human Evaluation of a Novel Polymer-Free Drug-Filled Stent: Angiographic, IVUS, OCT, and Clinical Outcomes From the RevElution Study. JACC Cardiovasc Interv. 2017 Jan 23;10(2):147-156. doi: 10.1016/j.jcin.2016.10.020.