RESOLUTE ONYX China Single Arm Study

Study Overview
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Brief Summary
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It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ 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 Onyx™ Stent System in China.

Detailed Description
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This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).

Official Title
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A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China

Conditions
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Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease

Intervention / Treatment
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* Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System<br>Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System<br>* Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Failure (TLF) | TLF | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | 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. | at the end of the index procedure or during hospital stay:estimated 7 days | 
| Lesion Success | 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. | at the end of the index procedure or during hospital stay: estimated 7 days | 
| Procedure Success | 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. | at the end of the index procedure or during hospital stay: estimated 7 days | 
| Major Adverse Cardiac Events (MACE) | 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 | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| Death (Cardiac and Non-cardiac) | All deaths | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI)) | All myocardial infarction data will be reported per Medtronic historical protocol definitions. | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| All revascularizations | Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| Target Vessel Failure (TVF) | TVF | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| Target Lesion Failure (TLF) | TLF | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| Stent Thrombosis (ST) | ST | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years | 
| In-stent late luminal loss | Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss | 9 months | 
| In-segment late luminal loss | Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss | 9 months | 
| In-stent and in-segment percent diameter stenosis (%DS) | Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS) | 9 months | 
| In-stent and in-segment binary restenosis rate | Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate | 9 months | 
| In-stent and in-segment minimal luminal diameter (MLD) | Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD) | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Adverse Cardiac Events (MACE), Myocardial Infarction (MI), Late Lumen Loss (LLL), Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST), PERCUTANEOUS CORONARY INTERVENTION (PCI)