Diabetes Mellitus Clinical Trial
Official title:
Comparison of Diabetes Mellitus and Non-diabetes Mellitus Patients for Surface Coverage After Two Types of Drug-eluting Stent Implantation (A Pilot Study)
Diabetic patients are prone to a diffuse and rapidly progressive form of atherosclerosis.
Both clinical and angiographic outcomes following percutaneous coronary intervention (PCI)
are poor in patients with DM compared with those without DM. Autopsy study has shown delayed
neointimal healing with inadequate endothelialization and persistent stent surface fibrin
deposition after DES implantation in DM patients. This might partially contribute to the
high risk of late stent thrombosis.
YINYI Polymer-Free paclitaxel stent is a domestic new type stent with bare metal base with
micro porous surface. However, limited data is available in vivo about the surface coverage
after stent implantation in DM patients because of lack of sensitive imaging modalities.
Optical coherence tomography (OCT) is an optical analogue of intravascular
ultrasound（IVUS）that allows high-resolution tomographic intravascular imaging. Furthermore,
several studies have demonstrated the feasibility of OCT to quantitatively evaluate the
surface coverage and stent conditions in the follow up after PCI .
Therefore, the aim of this study was to analyze the surface coverage and late malapposition
after two types of DES implantation in DM patients compared with non-DM patients by using
OCT and IVUS.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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