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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Coronary Artery Disease Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Resolute Integrity Stent

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

Group Type ACTIVE_COMPARATOR

Optical coherence tomography

Intervention Type DEVICE

Promus Stent

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

Group Type ACTIVE_COMPARATOR

Optical coherence tomography

Intervention Type DEVICE

Interventions

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Optical coherence tomography

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No