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

Barts & The London NHS Trust

Status: Completed

Conditions: Coronary Artery Disease; Diabetes

Treatments: Device: Optical coherence tomography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02060357

11/LO/0948

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Resolute Integrity Stent

Active Comparator group

Description:

Patients will be randomised in a 1:1 ratio to receive two different types of DES

Treatment:

Device: Optical coherence tomography

Promus Stent

Active Comparator group

Description:

Patients will be randomised in a 1:1 ratio to receive two different types of DES

Treatment:

Device: Optical coherence tomography