Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES) (OCT-DES)
Primary Purpose
Coronary Artery Disease, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optical coherence tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Diabetes Mellitus, PCI, Drug eluting stent, OCT
Eligibility Criteria
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
Sites / Locations
- London Chest Hospital, Barts Health NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Resolute Integrity Stent
Promus Stent
Arm Description
Patients will be randomised in a 1:1 ratio to receive two different types of DES
Patients will be randomised in a 1:1 ratio to receive two different types of DES
Outcomes
Primary Outcome Measures
Endothelial stent coverage
Endothelial coverage expressed as % of struts without coverage as measured by OCT
Secondary Outcome Measures
Neointimal hyperplasia
Neointimal hyperplasia (mm2) as measured by OCT
MACE
death, heart failure, myocardial infarction, stroke, need for repeat revascularisation
Full Information
NCT ID
NCT02060357
First Posted
January 20, 2014
Last Updated
August 6, 2015
Sponsor
Barts & The London NHS Trust
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02060357
Brief Title
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
Acronym
OCT-DES
Official Title
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Diabetes
Keywords
Diabetes Mellitus, PCI, Drug eluting stent, OCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Resolute Integrity Stent
Arm Type
Active Comparator
Arm Description
Patients will be randomised in a 1:1 ratio to receive two different types of DES
Arm Title
Promus Stent
Arm Type
Active Comparator
Arm Description
Patients will be randomised in a 1:1 ratio to receive two different types of DES
Intervention Type
Device
Intervention Name(s)
Optical coherence tomography
Primary Outcome Measure Information:
Title
Endothelial stent coverage
Description
Endothelial coverage expressed as % of struts without coverage as measured by OCT
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Neointimal hyperplasia
Description
Neointimal hyperplasia (mm2) as measured by OCT
Time Frame
6 month
Title
MACE
Description
death, heart failure, myocardial infarction, stroke, need for repeat revascularisation
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Mathur, FRCP FESC
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Chest Hospital, Barts Health NHS Trust
City
London
ZIP/Postal Code
E2 9JX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29632674
Citation
Hamshere S, Byrne A, Choudhury T, Gallagher SM, Rathod KS, Lungley J, Knight CJ, Kapur A, Jones DA, Mathur A. Randomised trial of the comparison of drug-eluting stents in patients with diabetes: OCT DES trial. Open Heart. 2018 Apr 5;5(1):e000705. doi: 10.1136/openhrt-2017-000705. eCollection 2018.
Results Reference
derived
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Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
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