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

Completed

• Conditions: Coronary artery disease; Circulatory System

• Registration Number: ISRCTN42475919
• Lead Sponsor: Royal Brompton and Harefield NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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/

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.