Medtronic RevElution Trial (RevElution)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Polymer-free DES (Drug Eluting Stent)
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease
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
Sites / Locations
- Eastern Heart Clinic - Prince of Wales Hospital
- The Prince Charles Hospital
- St. Andrew's Hospital
- Royal Adelaide Hospital
- Wesley Hospital / HeartCare Partners
- Flinders Medical Center
- St. Vincent's Hospital
- Royal Brisbane & Women's Hospital
- Monash Medical Center
- Northern Hospital
- Fiona Stanley Hospital
- John Hunter Hospital
- Royal North Shore Hospital
- Institute Dante Pazzanese of Cardiology
- National Heart Center Singapore
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Polymer-free DES (Drug Eluting Stent)
Arm Description
Outcomes
Primary Outcome Measures
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02480348
Brief Title
Medtronic RevElution Trial
Acronym
RevElution
Official Title
Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2015 (Actual)
Primary Completion Date
June 16, 2017 (Actual)
Study Completion Date
October 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Vascular
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polymer-free DES (Drug Eluting Stent)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Polymer-free DES (Drug Eluting Stent)
Primary Outcome Measure Information:
Title
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Eastern Heart Clinic - Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
St. Andrew's Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Wesley Hospital / HeartCare Partners
City
Auchenflower
Country
Australia
Facility Name
Flinders Medical Center
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Facility Name
St. Vincent's Hospital
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Monash Medical Center
City
Melbourne
ZIP/Postal Code
3168
Country
Australia
Facility Name
Northern Hospital
City
Melbourne
Country
Australia
Facility Name
Fiona Stanley Hospital
City
Murdoch
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Institute Dante Pazzanese of Cardiology
City
São Paulo
Country
Brazil
Facility Name
National Heart Center Singapore
City
Singapore
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
28104208
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.
Results Reference
derived
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Medtronic RevElution Trial
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