Coronary Artery Disease, Diabetes
Conditions
Keywords
Diabetes Mellitus, PCI, Drug eluting stent, OCT
Brief summary
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.
Interventions
DEVICEOptical coherence tomography
Sponsors
Medtronic
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial stent coverage | 6 month | Endothelial coverage expressed as % of struts without coverage as measured by OCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal hyperplasia | 6 month | Neointimal hyperplasia (mm2) as measured by OCT |
| MACE | 6 months | death, heart failure, myocardial infarction, stroke, need for repeat revascularisation |
Countries
United Kingdom
Outcome results
None listed