Contact information
Type
Scientific
Primary contact
Dr Miles Dalby
ORCID ID
Contact details
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
+44 (0)1895828990
m.dalby@rbht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The hypothesis of this study is that there is more complete stent strut coverage in the polymer free rapamycin eluting 'Yukon' stent (Translumina), compared with the durable polymer based rapamycin eluting stent 'Cypher' (Cordis) using optical coherence tomography at 3 months post implantation.
Ethics approval
Approval from UK Central Office of Research Ethics Committees (COREC) on 4th October 2006 (ref: 06/Q0404/61)
Study design
Single-centre two-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Coronary artery disease
Intervention
In brief all patients will be undergoing drug eluting intracoronary stent deployment as clinically indicated. Patients will be randomly allocated to receive a Yukon (rapamicin eluting polymer free) or Cypher (rapamicin eluting polymer coated) stent using standard clinical protocols according to the discretion of the implanting cardiologist. Patients will be systematically re-catheterised at 90 days and undergo optical coherence tomography.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Comparison of binary stent strut coverage between the Yukon (rapamicin eluting polymer free) and Cypher (rapamicin eluting polymer coated) groups at 90 day optical coherence tomography.
Secondary outcome measures
Comparison of mean neointimal thickness between the Yukon (rapamicin eluting polymer free) and Cypher (rapamicin eluting polymer coated) groups at 90 day optical coherence tomography.
Overall trial start date
20/10/2006
Overall trial end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18-75
2. Stable or unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI) but not ST-Elevation Myocardial Infarction (STEMI; primary Percutaneous Coronary Intervention (PCI) or rescue angioplasty) who have been pain-free for > 24h
3. Single or multiple lesions in a native coronary artery
4. 50-99% diameter stenosis
5. Lesion length 8-28mm (visually estimated)
6. Vessel diameter 2.5-3.5mm (visually estimated)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total 40 (20 each arm)
Participant exclusion criteria
1. Unprotected left mainstem lesion
2. Ostial lesion
3. Bifurcation lesion requiring side branch intervention
4. Severely calcified lesion that cannot be successfully pre-dilated
5. Marked tortuosity or angulation of target vessel
6. STEMI
7. Left Ventricular (LV) ejection fraction <20%
8. Pregnancy or breast feeding
9. Coexisting comorbidity limiting life expectancy to <24 months
10. Renal impairment with Creatinine (Cr) >200 µmol/L
Recruitment start date
20/10/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Harefield Hospital
Harefield
UB9 6JH
United Kingdom
Sponsor information
Organisation
Royal Brompton and Harefield NHS Trust (UK)
Sponsor details
Hill End Road
Harefield
UB9 6JH
United Kingdom
+44 (0)1895828990
m.dalby@rbht.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Translumina (Hechingen, Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19463468
Publication citations
-
Results
Moore P, Barlis P, Spiro J, Ghimire G, Roughton M, Di Mario C, Wallis W, Ilsley C, Mitchell A, Mason M, Kharbanda R, Vincent P, Sherwin S, Dalby M, A randomized optical coherence tomography study of coronary stent strut coverage and luminal protrusion with rapamycin-eluting stents., JACC Cardiovasc Interv, 2009, 2, 5, 437-444, doi: 10.1016/j.jcin.2009.01.010.