ISRCTN42475919CompletedNot Applicable
An optical coherence tomography study to determine stent coverage in polymer coated versus bare metal rapamycin eluting stents
Royal Brompton and Harefield NHS Trust (UK)0 sites40 target enrollmentStarted: June 25, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
- •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/
Investigators
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