Medtronic RevElution Trial

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Polymer-free DES (Drug Eluting Stent)

• Registration Number: NCT02480348
• Lead Sponsor: Medtronic Vascular

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-24
• Study Start: 2015-12-03
• Primary Completion: 2017-06-16
• Study Completion: 2019-10-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-02
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Polymer-free DES (Drug Eluting Stent)	Polymer-free DES (Drug Eluting Stent)	-

Primary Outcome Measures

Name	Time	Method
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.	9 months

Trial Locations

Locations (15)

St. Vincent's Hospital; 🇦🇺 Darlinghurst, Australia

Flinders Medical Center; 🇦🇺 Bedford Park, Australia

Royal North Shore Hospital; 🇦🇺 St Leonards, Australia

Institute Dante Pazzanese of Cardiology; 🇧🇷 São Paulo, Brazil

Wesley Hospital / HeartCare Partners; 🇦🇺 Auchenflower, Australia

Eastern Heart Clinic - Prince of Wales Hospital; 🇦🇺 Sydney, New South Wales, Australia

St. Andrew's Hospital; 🇦🇺 Adelaide, South Australia, Australia

Royal Brisbane & Women's Hospital; 🇦🇺 Herston, Australia

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, Australia

Northern Hospital; 🇦🇺 Melbourne, Australia

John Hunter Hospital; 🇦🇺 New Lambton, Australia

Fiona Stanley Hospital; 🇦🇺 Murdoch, Australia

Monash Medical Center; 🇦🇺 Melbourne, Australia

National Heart Center Singapore; 🇸🇬 Singapore, Singapore