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OpenTrials
Completed

NCT Number: NCT02060357

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Chest Hospital, Barts Health NHS Trust

London, E2 9JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

optical coherence tomography

Device

Primary outcomes

  1. Endothelial stent coverage

    Time frame: 6 month

    Endothelial coverage expressed as % of struts without coverage as measured by OCT

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: OCT-DES

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 12, 2014
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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