Coronary Heart Disease Clinical Trial
Official title:
BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in
terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which
will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned
undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority
was met, superiority test will be planned.
About 70 patients with clinical evidence of ischemic heart disease and / or a positive
functional study and documented stable angina pectoris (Canadian cardiovascular society
classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native,
previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing
implantation of BuMA stent or EXCEL stent (in a 1:1 ratio).
All of the patients will receive 6 months dual antiplatelet therapy and they will be
followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be
conducted at 3 months (including angiographic/OCT investigation), 6 months, 1 and 2 years
post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and
Secondary Endpoints.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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