China Resolute Integrity 34/38 mm Study

Study Overview
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Brief Summary
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To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Official Title
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Evaluation of the Clinical Safety and Efficacy of the 34/38 mm Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Subjects According to the Indication for Use.

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 Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)


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 Instructions for Use of the Resolute Integrity 34/38 mm stent The subject can have either a single lesion, or two lesions located in separate target vessels treated during the index procedure. Each lesion length needs to be ≤35mm with at least one lesion length >27mm and≤ 35mm and amenable for treatment with a Resolute Integrity 34/38 mm stent Key Exclusion Criteria: STEMI within 24 hours Left main disease Bifurcation disease

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary Stent<br>Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System (34/38 mm) | Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System(34/38 mm)<br>* The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss, in stent | Late lumen loss measured by quantitative coronary angiography (QCA) | 9 months (m) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) | Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Death | All death | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Myocardial infarction | All MI, and Target Vessel Myocardial Infarction (TVMI) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| All revascularizations | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Target Vessel Failure (TVF) | TVF | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Target Lesion Failure (TLF) | TLF | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Stent Thrombosis (ST) | ST | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years | 
| Device Success | The attainment of <50% residual stenosis of the target lesion using only the assigned device. 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 index procedure, an expected average of 3 days | 
| Lesion Success | The attainment of <50% residual stenosis of the target lesion using any percutaneous method. The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method. These measurements will be made by the independent angiographic core laboratory. | At the end of index procedure, an expected average of 3 days | 
| Procedure Success | The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE. The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND a TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. | Duration of hospital stay, an expected average of 5 days | 
| In-stent and in-segment percent diameter stenosis (%DS) | In-stent and in-segment percent diameter stenosis (%DS) | 9 months | 
| In-stent and in-segment binary restenosis rate | In-stent and in-segment binary restenosis rate | 9 months | 
| In-stent and in-segment minimal luminal diameter (MLD) | In-stent and in-segment minimal luminal diameter (MLD) | 9 months | 
| In-segment late luminal loss | 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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Long Lesion, In-stent Late Lumen Loss (LLL), Major Adverse Cardiac Events (MACE), MYOCARDIAL INFARCTION (MI), TARGET VESSEL REVASCULARIZATION (TVR), TARGET LESION REVASCULARIZATION (TLR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST)