Medtronic RevElution Trial

Coronary Artery Disease Clinical Trial

— RevElution  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480348
• Other study ID #: Version 5.0, 29 JUL 2019
• Status: Completed
• Phase: N/A
• Start date: December 3, 2015
• Est. completion date: October 21, 2019

Study information

• Verified date: July 2020
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: October 21, 2019
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Polymer-free DES (Drug Eluting Stent)

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	St. Andrew's Hospital	Adelaide	South Australia
Australia	Wesley Hospital / HeartCare Partners	Auchenflower
Australia	Flinders Medical Center	Bedford Park
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	St. Vincent's Hospital	Darlinghurst
Australia	Royal Brisbane & Women's Hospital	Herston
Australia	Monash Medical Center	Melbourne
Australia	Northern Hospital	Melbourne
Australia	Fiona Stanley Hospital	Murdoch
Australia	John Hunter Hospital	New Lambton
Australia	Royal North Shore Hospital	St Leonards
Australia	Eastern Heart Clinic - Prince of Wales Hospital	Sydney	New South Wales
Brazil	Institute Dante Pazzanese of Cardiology	São Paulo
Singapore	National Heart Center Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Vascular

Countries where clinical trial is conducted

Australia,  Brazil,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.		9 months