SYNERGY China: Assess SYNERGY Stent in China

Study Overview
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Brief Summary
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Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.

Detailed Description
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The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Official Title
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SYNERGY China: A Prospective, Multicenter Trial to Assess the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Device: SYNERGYTM Coronary Stent System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Subject must be at least 18 -75 years of age Subject is eligible for percutaneous coronary intervention (PCI) Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and <100% with thrombolysis in Myocardial Infarction (TIMI) flow >1 Key Exclusion Criteria: Planned PCI (including staged procedures) or CABG after the index procedure Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant. Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L) Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate. Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: SYNERGYTM Coronary Stent System<br>Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System | Device: SYNERGYTM Coronary Stent System<br>* SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success Rate | Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion Revascularization (TLR) Rate |  | 30 days | 
| Target Lesion Failure (TLF) Rate |  | 30 days | 
| Target Vessel Revascularization (TVR) Rate |  | 30 days | 
| Target Vessel Failure (TVF) Rate |  | 30 days | 
| Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate |  | 30 days |