RESOLUTE ONYX China Single Arm Study (NCT03471845) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
RESOLUTE ONYX China Single Arm Study
China591 participantsStarted 2018-03-30
Plain-language summary
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyxâ„¢ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyxâ„¢ Stent System in China.
Who can participate
Age range18 Years
SexALL
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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, and the IB of Resolute Onyx 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 5.0 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