RESOLUTE ONYX China RCT Study

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).

• Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System (Device): Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
• Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (Device): Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Primary outcomes

• In-stent Late lumen loss measured by quantitative coronary angiography (QCA) [9 months]: Late lumen loss measured by quantitative coronary angiography (QCA)

Secondary outcomes

• Device Success [at the end of the index procedure or during hospital stay: estimated 7 days]: Definition 1: The attainment of <50% residual stenosis of the target lesion using only the assigned device. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
• Lesion Success [at the end of the index procedure or during hospital stay: estimated 7 days]: Definition 1: The attainment of <50% residual stenosis of the target lesion using any percutaneous method. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
• Procedure Success [at the end of the index procedure or during hospital stay: estimated 7 days]: Definition 1: The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE. Definition 2: The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
• Major Adverse Cardiac Events (MACE) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: Defined as composite of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
• Death (Cardiac and Non-cardiac) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: All deaths
• Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI)) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: All myocardial infarction data will be reported per Medtronic historical protocol definitions.
• All revascularizations [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
• Target Vessel Failure (TVF) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: TVF
• Target Lesion Failure (TLF) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: TLF
• Stent Thrombosis (ST) [30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years]: ST
• In-stent and in-segment percent diameter stenosis (%DS) [9 months]: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
• In-stent and in-segment binary restenosis rate [9 months]: Angiographic measures:In-stent and in-segment binary restenosis rate
• In-stent and in-segment minimal luminal diameter (MLD) [9 months]: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
• In-segment late luminal loss [9 months]: Angiographic measures: In-segment late luminal loss

Sex: All, ages: 18 Years to any

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

• Study Protocol (PDF, 2019-02-13)
• Statistical Analysis Plan (PDF, 2020-10-22)

• Yongjian Wu, MD, Principal investigator, Fuwai Hospital, Chinese Academy of Medical Science