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Medtronic RevElution Trial (RevElution)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02480348
First Posted: June 24, 2015
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Vascular
  Purpose
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.

Condition Intervention
Coronary Artery Disease Device: Polymer-free DES (Drug Eluting Stent)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography. [ Time Frame: 9 months ]

Estimated Enrollment: 100
Actual Study Start Date: June 2015
Estimated Study Completion Date: February 2021
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Polymer-free DES (Drug Eluting Stent) Device: Polymer-free DES (Drug Eluting Stent)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480348


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02480348     History of Changes
Other Study ID Numbers: Version 4.0, 04 AUG 2017
First Submitted: June 19, 2015
First Posted: June 24, 2015
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases