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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN42475919
Enrollment
40
Registered
2007-06-25
Start date
2006-10-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery disease Circulatory System Coronary artery disease

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

Sponsors

Royal Brompton and Harefield NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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)

Exclusion criteria

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 200 µmol/L

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026