Medtronic RevElution Trial (RevElution)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Polymer-free DES (Drug Eluting Stent)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital
  • Auchenflower, Australia
    • Wesley Hospital / HeartCare Partners
  • Bedford Park, Australia, 5042
    • Flinders Medical Center
  • Darlinghurst, Australia, 2010
    • St. Vincent's Hospital
  • Herston, Australia, 4029
    • Royal Brisbane & Women's Hospital
  • Melbourne, Australia
    • Northern Hospital
  • Melbourne, Australia, 3168
    • Monash Medical Center
  • Murdoch, Australia
    • Fiona Stanley Hospital
  • New Lambton, Australia
    • John Hunter Hospital
  • St Leonards, Australia, 2065
    • Royal North Shore Hospital
  • New South Wales
    • Sydney, New South Wales, Australia, 2031
      • Eastern Heart Clinic - Prince of Wales Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • St. Andrew's Hospital
• Brazil
  • São Paulo, Brazil
    • Institute Dante Pazzanese of Cardiology
• Singapore
  • Singapore, Singapore
    • National Heart Center Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Polymer-free DES (Drug Eluting Stent)	Device: Polymer-free DES (Drug Eluting Stent)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medtronic Vascular

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2015
• Primary Completion (ACTUAL): June 16, 2017
• Study Completion (ACTUAL): October 21, 2019

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (ESTIMATE): June 24, 2015

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Version 5.0, 29 JUL 2019