| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN42475919 |
| Date ISRCTN assigned | 25/06/2007 |
| Local reference number(s) | N/A |
| Public title | An optical coherence tomography study to determine stent coverage in polymer coated versus bare metal rapamycin eluting stents |
| Scientific title |
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| Acronym | N/A |
| Disease/condition/study domain | Coronary artery disease |
| 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. |
| Design/methodology | Single-centre, two-arm, randomised controlled trial. |
| Research ethics review | Approval from UK Central Office of Research Ethics Committees (COREC) on 4th October 2006 (ref: 06/Q0404/61) |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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 |
| Patient information material |
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| Anticipated start date | 20/10/2006 |
| Anticipated end date | 01/08/2007 |
| Status of trial | Completed |
| Target number of participants | Total 40 (20 each arm) |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | Translumina (Hechingen, Germany) |
| Sponsor name | Royal Brompton and Harefield NHS Trust (UK) |
| Sponsor details | Hill End Road
Harefield
United Kingdom
UB9 6JH |
| Sponsor telephone | +44 (0)1895828990 |
| Sponsor fax | +44 (0)1895826581 |
| Sponsor email | m.dalby@rbht.nhs.uk |
| Sponsor website | http://www3.rbht.nhs.uk/ |
| Contact name | Dr Miles Dalby |
| Contact details | Harefield Hospital
Hill End Road
Harefield
United Kingdom
UB9 6JH |
| Contact telephone | +44 (0)1895828990 |
| Contact fax | +44 (0)1895826581 |
| Contact email | m.dalby@rbht.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN42475919 |
| Date last extracted from ISRCTN register | 17/04/2008 |
