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

Sponsor

Barts & The London NHS Trust (Other)

Overall Status

Completed

CT.gov ID

NCT02060357

Collaborator

Medtronic (Industry)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Diabetes	Device: Optical coherence tomography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Resolute Integrity Stent

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

Device: Optical coherence tomography

Active Comparator: Promus Stent

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

Device: Optical coherence tomography

Outcome Measures

Primary Outcome Measures

Endothelial stent coverage [6 month]
Endothelial coverage expressed as % of struts without coverage as measured by OCT

Secondary Outcome Measures

Neointimal hyperplasia [6 month]
Neointimal hyperplasia (mm2) as measured by OCT
MACE [6 months]
death, heart failure, myocardial infarction, stroke, need for repeat revascularisation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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