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
Scientific
Harefield Hospital
Hill End Road
Harefield
UB9 6JH
United Kingdom
| Phone | +44 (0)1895828990 |
|---|---|
| m.dalby@rbht.nhs.uk |
Study information
| Study design | Single-centre two-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 20/10/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Total 40 (20 each arm) |
| Key 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) |
| Key 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 |
| Date of first enrolment | 20/10/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Harefield Hospital
Harefield
UB9 6JH
United Kingdom
UB9 6JH
United Kingdom
Sponsor information
Royal Brompton and Harefield NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Hill End Road
Harefield
UB9 6JH
England
United Kingdom
| Phone | +44 (0)1895828990 |
|---|---|
| m.dalby@rbht.nhs.uk | |
| Website | http://www3.rbht.nhs.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
