Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
109 participants
INTERVENTIONAL
2015-12-03
2019-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Polymer-free DES (Drug Eluting Stent)
Polymer-free DES (Drug Eluting Stent)
Interventions
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Polymer-free DES (Drug Eluting Stent)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Vascular
INDUSTRY
Responsible Party
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Locations
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Eastern Heart Clinic - Prince of Wales Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
St. Andrew's Hospital
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Wesley Hospital / HeartCare Partners
Auchenflower, , Australia
Flinders Medical Center
Bedford Park, , 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
Institute Dante Pazzanese of Cardiology
São Paulo, , Brazil
National Heart Center Singapore
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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Version 5.0, 29 JUL 2019
Identifier Type: -
Identifier Source: org_study_id
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