Coronary Artery DiseaseOCT-DESNCT02060357
Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes (OCT-DES)
A study testing Optical coherence tomography in people with Coronary Artery Disease and Diabetes, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Diabetes
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London Chest Hospital, Barts Health NHS Trust
London, E2 9JX
About this study
Official title: Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes
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.
- Conditions
- Coronary Artery Disease, Diabetes
- Being tested
- Optical coherence tomography
- Keywords
- Diabetes Mellitus, PCI, Drug eluting stent, OCT
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDevice
| Study group | Role | What they receive |
|---|---|---|
| Resolute Integrity Stent | Active comparator | Patients will be randomised in a 1:1 ratio to receive two different types of DES Receives: Device: Optical coherence tomography |
| Promus Stent | Active comparator | Patients will be randomised in a 1:1 ratio to receive two different types of DES Receives: Device: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial stent coverage
Endothelial coverage expressed as % of struts without coverage as measured by OCT
Measured: 6 month
Secondary outcomes (2)
Neointimal hyperplasia
Neointimal hyperplasia (mm2) as measured by OCT
Measured: 6 month
MACE
death, heart failure, myocardial infarction, stroke, need for repeat revascularisation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startNov 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Anthony Mathur, Barts & The London NHS Trust
- Investigators
- Anthony Mathur, FRCP FESC, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060357
- Sponsor's protocol ID
- 11/LO/0948
- Acronym
- OCT-DES
- Status last verified
- Aug 2015
- First submitted
- 20 Jan 2014
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29632674
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two New Generation Drug Eluting Stents in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02060357
- Acronym / sponsor ID
- OCT-DES / 11/LO/0948
- Conditions
- Coronary Artery Disease, Diabetes
- Keywords
- Diabetes Mellitus, PCI, Drug eluting stent, OCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resolute Integrity Stent | Active comparator | Device: Optical coherence tomographyPatients will be randomised in a 1:1 ratio to receive two different types of DES |
| Promus Stent | Active comparator | Device: Optical coherence tomographyPatients will be randomised in a 1:1 ratio to receive two different types of DES |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical coherence tomography | Device | Promus Stent, Resolute Integrity Stent |
Primary outcome
Endothelial stent coverage
Time frame: 6 month
Endothelial coverage expressed as % of struts without coverage as measured by OCT
2 secondary outcomes
Neointimal hyperplasia
Time frame: 6 month
MACE
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Derived from this study: PubMed 29632674Hamshere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Mathur, FRCP FESC principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography in people with Coronary Artery Disease and Diabetes, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial stent coverage (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02060357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.