Condition category
Circulatory System
Date applied
16/06/2007
Date assigned
25/06/2007
Last edited
02/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www3.rbht.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19463468

Publication citations

  1. 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.

Additional files

Editorial Notes