Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms

Study Overview
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Brief Summary
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The purpose of the trial is to directly compare the Cobalt Chromium platform everolimus-eluting stent, Xience Prime™, with the Platinum Chromium platform everolimus-eluting stent, Promus Element™, in relation to stent scaffolding shape, position with the heart blood vessel and extent of tissue coverage (at 6 months) using optical coherence tomography. Hypotheses: The alloy composition and strut design of a drug-eluting stent has a direct bearing on stent apposition measured using OCT. Stent design and alloy composition have a direct influence on radial support and scaffold shrinkage.

Official Title
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Apposition Assessed Using Optical Coherence Tomography of Chromium Stents Eluting Everolimus From Cobalt Versus Platinum Alloy Platforms.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Everolimus eluting stents


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction Presence of one or more coronary artery stenosis > 50% in a native coronary artery with a reference diameter ranging from 2.25 to 4.25 mm which can be covered with one or multiple stents No limitation to the number of treated lesions or number of vessels according to the randomization group De-novo native coronary disease with complex lesions involving: Bifurcations, chronic occlusions > 3 months, lesions > 20mm in length or moderately/heavily calcified lesions of any length Exclusion Criteria: Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, platinum chromium, everolimus, contrast material Acute ST-segment elevation myocardial infarction Type A lesion including vessel angulation <45 degrees Bypass graft Inability to provide informed consent Pregnancy Planned surgery within 12 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period Left ventricular ejection fraction < 25% Serum creatinine > 180mmol/L

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cobalt Chromium Everolimus-eluting stent (Xience Prime)<br>Cobalt Chromium Everolimus-eluting stent (Xience Prime) | Device: Everolimus eluting stents<br> <br> |
| Active Comparator: Platinum Chromium Everolimus-eluting stent (Promus Element)<br>Platinum Chromium Everolimus-eluting stent (Promus Element) | Device: Everolimus eluting stents<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Percent incomplete stent apposition using OCT of the CoCr-EES versus the PtCr-EES stent inflated to nominal pressure and following optimal post-dilatation. Stent length (mm) at implantation following nominal pressure and following post-dilatation |  | Immediately following stent deployment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent struts |  | 6 mths post initial PCI procedure | 
| Mean neointimal tissue thickness (microns) |  | 6 months post initial PCI Procedure | 
| Stent length (mm) measured using OCT |  | 6 months post initial PCI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, stents, optical imaging