Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)

Study Overview
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Brief Summary
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The aim of this study is a comparative evaluation of re-endothelailisation of the Integrity Resolute zotarolimus eluting stent (Medtronic) and of the Promus Element erolimus eluting stent (Boston Scientific), in patients with diabetes. We plan to compare endothelial coverage and neointimal proliferation using OCT and compare this data to published results from conventional stents.

Official Title
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Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes

Conditions
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Coronary Artery Disease, Diabetes

Intervention / Treatment
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* Device: Optical coherence tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known to have diabetes Scheduled for percutaneous coronary intervention (PCI) with a stenosis suitable for DES implantation and OCT imaging Reference vessel diameter over 2.5mm by operator assessment. Able to understand and sign the written Informed Consent Form. Able and willing to follow the Protocol requirements. Exclusion Criteria: Inability to consent Cardiogenic shock Planned use of a bare metal stent LMS coronary artery disease Congestive cardiac failure or low ejection fraction (LVEF <35%) Lesions unsuitable for OCT Total length of stented lesion greater than 55mm (total combination of stent lengths) Age less than 18 years or age greater than 80 years Planned surgical procedure ≤ 12 months post PCI procedure Patient demonstrates evidence of thrombocytopenia (platelet count < 100,000/mm3) Patients with contraindications to ASA, clopidogrel, or prasogrel Patient is currently on warfarin, or possibility of treatment with warfarin during the following 12 months post index procedure Allergy to contrast Patients enrolled in another active clinical trial. Potential for non-compliance towards the requirements in the study protocol. Serious known concomitant disease with a life expectancy of less than one year Follow-up impossible (no fixed abode, etc) Patients with renal impairment (Creatinine >200mmol/L) Subjects of childbearing potential

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resolute Integrity Stent<br>Patients will be randomised in a 1:1 ratio to receive two different types of DES | Device: Optical coherence tomography<br> <br> |
| Active Comparator: Promus Stent<br>Patients will be randomised in a 1:1 ratio to receive two different types of DES | Device: Optical coherence tomography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial stent coverage | Endothelial coverage expressed as % of struts without coverage as measured by OCT | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal hyperplasia | Neointimal hyperplasia (mm2) as measured by OCT | 6 month | 
| MACE | death, heart failure, myocardial infarction, stroke, need for repeat revascularisation | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCT, Diabetes Mellitus, Drug eluting stent, PCI