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Active (not recruiting) Not applicable NCT03466151

RESOLUTE ONYX China RCT Study

No applicable phase (e.g. observational)
Conditions: Ischemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis Coronary Artery Disease

Sponsor: Medtronic Vascular

trial.available_in: БГ
Overview
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.
Description
This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint\_LLL), and annual assessments from 1-5 years).
Who can participate
Key Inclusion Criteria: * The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, the IB of Resolute Onyx stent, and the IFU of Resolute Integrity stent * The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel(including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 4.0 mm Key Exclusion Criteria: * Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated * PCI of the target vessel within 9 months prior to the procedure * Active bleeding * Subjects with a life expectancy of less than 12 months * Participation in another clinical study * Pregnant, or lactating women
Interventions
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
DEVICE
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
DEVICE
Locations 2
China (2)
Fuwai Hospital, Chinese Academy of Medical Science
Beijing
Shengjing Hospital of China Medical University
Shenyang , Liaoning
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
12.04.2018
Completion date
31.07.2026
Registry ID
NCT03466151
Source
clinicaltrials.gov
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