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

Coronary Artery Disease Clinical Trial

— OCT-DES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060357
• Other study ID #: 11/LO/0948
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: August 6, 2015
• Start date: November 2011
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Research Ethics Committee: United Kingdom
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes
• Myocardial Ischemia

Intervention

Device:
• Optical coherence tomography

Locations

Country	Name	City	State
United Kingdom	London Chest Hospital, Barts Health NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	Medtronic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial stent coverage	Endothelial coverage expressed as % of struts without coverage as measured by OCT	6 month	No
Secondary	Neointimal hyperplasia	Neointimal hyperplasia (mm2) as measured by OCT	6 month	No
Secondary	MACE	death, heart failure, myocardial infarction, stroke, need for repeat revascularisation	6 months	Yes