Clinical trial NCT02060357: Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
Official title: Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Diabetes
Keywords: Diabetes Mellitus
PCI
Drug eluting stent
OCT
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-02-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Endothelial stent coverage
timeFrame: 6 month
Secondary outcomes:
measure: Neointimal hyperplasia
timeFrame: 6 month
measure: MACE
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London Chest Hospital, Barts Health NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Anthony Mathur, FRCP FESC
role: PRINCIPAL_INVESTIGATOR
References:
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.