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

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ClinicalTrials.gov Identifier: NCT02060357
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : August 7, 2015
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Anthony Mathur, Barts & The London NHS Trust

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Primary Outcome Measures :
  1. Endothelial stent coverage [ Time Frame: 6 month ]
    Endothelial coverage expressed as % of struts without coverage as measured by OCT


Secondary Outcome Measures :
  1. Neointimal hyperplasia [ Time Frame: 6 month ]
    Neointimal hyperplasia (mm2) as measured by OCT

  2. MACE [ Time Frame: 6 months ]
    death, heart failure, myocardial infarction, stroke, need for repeat revascularisation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060357


Locations
United Kingdom
London Chest Hospital, Barts Health NHS Trust
London, United Kingdom, E2 9JX
Sponsors and Collaborators
Barts & The London NHS Trust
Medtronic
Investigators
Principal Investigator: Anthony Mathur, FRCP FESC Barts & The London NHS Trust
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anthony Mathur, Professor, Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT02060357     History of Changes
Other Study ID Numbers: 11/LO/0948
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015

Keywords provided by Anthony Mathur, Barts & The London NHS Trust:
Diabetes Mellitus
PCI
Drug eluting stent
OCT

Additional relevant MeSH terms:
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases