An optical coherence tomography study to determine stent coverage in polymer coated versus bare metal rapamycin eluting stents

ISRCTN ISRCTN42475919
DOI https://doi.org/10.1186/ISRCTN42475919
Secondary identifying numbers N/A
Submission date
16/06/2007
Registration date
25/06/2007
Last edited
02/12/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Miles Dalby
Scientific

Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom

Phone +44 (0)1895828990
Email m.dalby@rbht.nhs.uk

Study information

Study designSingle-centre two-arm randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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(s)Approval from UK Central Office of Research Ethics Committees (COREC) on 4th October 2006 (ref: 06/Q0404/61)
Health condition(s) or problem(s) studiedCoronary artery disease
InterventionIn 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 typeOther
Primary outcome measureComparison 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 measuresComparison 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 study start date20/10/2006
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participantsTotal 40 (20 each arm)
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment20/10/2006
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Harefield Hospital
Harefield
UB9 6JH
United Kingdom

Sponsor information

Royal Brompton and Harefield NHS Trust (UK)
Hospital/treatment centre

Hill End Road
Harefield
UB9 6JH
England
United Kingdom

Phone +44 (0)1895828990
Email m.dalby@rbht.nhs.uk
Website http://www3.rbht.nhs.uk/
ROR logo "ROR" https://ror.org/02218z997

Funders

Funder type

Not defined

Translumina (Hechingen, Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2009 Yes No