RESOLUTE ONYX China RCT Study (NCT03466151) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RESOLUTE ONYX China RCT Study
China550 participantsStarted 2018-04-12
Plain-language summary
It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyxâ„¢ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrityâ„¢ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
In-stent Late lumen loss measured by quantitative coronary angiography (QCA)