Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use (CHINA RESOLUTE INTEGRITY STUDY)

Study Overview
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Brief Summary
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The purpose of this study is to conduct a prospective, multi-center, single arm, non-randomized evaluation of acute outcomes in Chinese subjects, including those eligible for percutaneous transluminal coronary angioplasty (PTCA) with a reference vessel diameter of 2.25 mm to 4.0 mm, with the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System.

Detailed Description
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This is a Pre-market, Prospective, Multi-center, Single arm, Non-randomized Study. The objective of this study is to: To assess the deliverability of the Resolute Integrity Stent for suitable patients according to Indication for Use with a reference vessel diameter (RVD) of 2.25 mm to 4.0 mm in 200 evaluable patients To assess the in-hospital Major Adverse Cardiac Event (MACE) rate To collect data on resource utilization in the catheterization lab. At least 200 evaluable patients from about 15 study centers in China who meet the eligibility criteria and sign the informed consent form will participate in this study. The expected time of participation in the study for each subject is from informed consent sign-off up to hospital discharge. An angiographic core laboratory and a Clinical Events Committee (CEC) will be utilized. Adjudication of pre-specified clinical endpoint events will be done by an independent Clinical Events Committee. An angiographic core laboratory will review all baseline, procedural, and clinical event angiograms for all patients.

Official Title
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CHINA RESOLUTE INTEGRITY STUDY Acute Safety, Deliverability and Efficacy of the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Suitable Patients According to Indication for Use --A Prospective, Multi-center, Single Arm, Non-randomized Study

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

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is older than or equal to 18 years The patient 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 stent The patient or legal representative has been informed of the nature of the trial and has consented to participate and authorized the collection and release of his/her medical information by signing a Patient Informed Consent Form Intention to implant at least one Resolute Integrity stent during percutaneous coronary intervention (PCI) Patient agrees to have all study procedures performed, and is willing to comply with all protocol-required evaluations Exclusion Criteria: Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, clopidogrel and ticlopidine, cobalt, nickel, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative A woman who is pregnant, planning to be pregnant or lactating Currently participating in another trial Situation that will prevent dual anti-platelet therapy to be maintained throughout the peri-surgical period Previous enrollment in the China Resolute Integrity Study

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: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System<br>This is a Single arm, Non-randomized Study. All patients meet the eligibility criteria and sign the informed consent form will participate in this study. | Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Specific Procedural Success | Defined as device success (the attainment of less than 50% residual stenosis of the target lesion using only the study device) and no in-hospital MACE (composite of death, myocardial infarction, emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization). | Participants will be followed for the duration of hospital stay, an expected average of 5 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery Success | Defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location. | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Device Success | defined as the attainment of less than 50% residual stenosis of the target lesion using only the Resolute Integrity stent. | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Lesion Success | Defined as the attainment of less than 50% residual stenosis by any percutaneous method. | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Procedure Success | Defined as the attainment of less than 50% residual stenosis by any percutaneous method and no in-hospital MACE. | Participants will be followed for the duration of hospital stay, an expected average of 5 days. | 
| In-hospital Major Adverse Cardiac Events (MACE) | Defined as the composite of as in-hospital death, myocardial infarction (Q-wave and non Q-wave), emergent coronary bypass surgery, or repeat target lesion revascularization (TLR; clinically driven/clinically indicated) by percutaneous or surgical method. | Participants will be followed for the duration of hospital stay, an expected average of 5 days. | 
| In-hospital Target Lesion Failure (TLF) | Defined as the composite of cardiac death, myocardial infarction (not clearly attributable to a non-target vessel) or target lesion revascularization (TLR; clinically indicated). | Participants will be followed for the duration of hospital stay, an expected average of 5 days. | 
| Procedure time (min) | Resource Utilization | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Contrast volume used (ml) | Resource Utilization | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Usage of guiding catheters | Resource Utilization | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Usage of guide wires | Resource Utilization | Participants will be followed at the end of index procedure, an expected average of 3 days. | 
| Usage of angioplasty balloons | Resource Utilization | Participants will be followed at the end of index procedure, an expected average of 3 days. |