RESOLUTE ONYX China RCT Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

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
* Device: Resolute Integrity™ 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, 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 Randomization
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>|
| Active Comparator: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System<br>Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System | Device: Resolute Integrity™ 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 |
| --- | --- | --- |
| In-stent Late lumen loss measured by quantitative coronary angiography (QCA) | Late lumen loss measured by quantitative coronary angiography (QCA) | 9 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, 1 year, 2 years,3 years, 4 years, 5 years | 
| Death (Cardiac and Non-cardiac) | All deaths | 30 day, 6 months, 9 months, 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, 1 year, 2 years,3 years, 4 years, 5 years | 
| All revascularizations | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years | 
| Target Vessel Failure (TVF) | TVF | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years | 
| Target Lesion Failure (TLF) | TLF | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years | 
| Stent Thrombosis (ST) | ST | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years | 
| In-stent and in-segment percent diameter stenosis (%DS) | Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS) | 9 months | 
| In-stent and in-segment binary restenosis rate | Angiographic measures:In-stent and in-segment binary restenosis rate | 9 months | 
| In-stent and in-segment minimal luminal diameter (MLD) | Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD) | 9 months | 
| In-segment late luminal loss | Angiographic measures: In-segment late luminal loss | 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), The Randomized Controlled Trial, PERCUTANEOUS CORONARY INTERVENTION (PCI)