Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Study Overview
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Brief Summary
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Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. However, the efficacy of the PtCr-EES for complex coronary artery diseases subsets such as chronic total occlusion, bifurcation lesion, left main trunk disease, and small vessel diseases is still unknown.

Official Title
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Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient with ischemic heart disease including stable angina pectoris and acute coronary syndrome Male or non-pregnant female Key lesion inclusion criteria as follows Multi-vessel diseases Long lesion (lesion length >30mm by visual estimation) Small vessel disease (reference diameter <2.5mm by visual estimation) Bifurcation lesion Ostial lesion Calcified lesion Protected or non-protected left main trunk disease Chronic total occlusion In stent restenosis of bare metal stent or everolimus-eluting stent Exclusion Criteria: Hypersensitivity to cobalt chromium, everolimus, heparin, aspirin, ticlopidine, clopidogrel or X-ray contrast media. Serum creatinine level >3.0 mg/dL Other concomitant disease or medical condition that could impact patient/procedural outcomes, such as history of bleeding diathesis or cancer within 5 years.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platinum chromium everolimus-eluting stent<br> | Device: platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful stent delivery with final percent diameter stenosis less than 50% at minimum lumen diameter site |  | In hospital | 
| Target lesion revascularization |  | 12 month | 
| Target vessel revascularization |  | 12 month | 
| Myocardial infarction |  | 24 month | 
| Cardiac death |  | 24 month | 
| Major adverse cardiac event including cardiac death, myocardial infarction, and target vessel revascularization |  | 24 month | 
| Stent thrombosis (acute, sub-acute, late,and very late) defined by Academic Research Consortium (ARC) |  | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic total occlusion, Bifurcation lesion, Left main trunk lesion, Small vessel disease, Multi vessel disease