NCT02060357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

3.3 years

First QC Date

January 20, 2014

Last Update Submit

August 6, 2015

Conditions

Coronary Artery DiseaseDiabetes

Keywords

Diabetes MellitusPCIDrug eluting stentOCT

Outcome Measures

Primary Outcomes (1)

  • Endothelial stent coverage

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

    6 month

Secondary Outcomes (2)

  • Neointimal hyperplasia

    6 month

  • MACE

    6 months

Study Arms (2)

Resolute Integrity Stent

ACTIVE COMPARATOR

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

Device: Optical coherence tomography

Promus Stent

ACTIVE COMPARATOR

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

Device: Optical coherence tomography

Interventions

Optical coherence tomographyDEVICE
Promus StentResolute Integrity Stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Chest Hospital, Barts Health NHS Trust

London, E2 9JX, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29632674DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseDiabetes Mellitus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Anthony Mathur, FRCP FESC

    Barts & The London NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2014

First Posted

February 12, 2014

Study Start

November 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

GB(1)