Coronary Heart Disease Clinical Trial
Official title:
Optical Coherence Tomography Assessment of Intimal Tissue and Malapposition: A Randomized Comparison of the Biolimus A9-eluting and Everolimus-eluting Coronary Stents
The purpose of this study is to use a high-resolution intracoronary imaging modality, called optical coherence tomography (OCT) to examine two different types of coronary artery stents used to treat patients with coronary artery disease.
The development of coronary stents has significantly improved the safety and efficacy of
percutaneous coronary intervention (PCI) compared to balloon angioplasty alone.
Nevertheless, restenosis is still encountered in 20 to 40% of coronary lesions after
implantation of bare metal stents, inferring frequent repeat revascularization procedures
with a negative impact on quality of life and health care expenditures. Drug-eluting stents
(DES), with their controlled release of therapeutic agents, have significantly reduced the
rate of major adverse cardiac events (MACE) following coronary stent implantation, primarily
by a reduction in restenosis and target lesion revascularization.
Optical coherence tomography (OCT) is an optical analogue of intravascular ultrasound
(IVUS): it uses an infrared light source (wavelength 1310nm) and measures the backscatter of
light in a technique similar to conventional ultrasound. With this technique a resolution up
to 10μm in-vivo has been reported, a far better level of resolution compared with IVUS.
Optical coherence tomography has been used in vivo and has detected early atherosclerotic
plaques previously not visualised by IVUS. Segments with strut malapposition and the
presence or thickness of neointimal hyperplasia can also be more accurately assessed with
OCT compared with IVUS.
The present study will utilize the imaging capabilities of OCT to assess stent strut
malapposition and tissue coverage in two different types of DES. The biolimus-eluting stent
eludes biolimus from a biodegradable polylactic acid polymer on the abluminal surface of a
stainless steel stent. This stent will be compared in a randomized fashion to the permanent
polymer based everolimus-eluting coronary stent made of cobalt chromium alloy.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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