Last updated on May 2018

A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT

Brief description of study

The objective of this study is a comparative evaluation of BuMA Supreme stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.

Detailed Study Description

This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme stent (20 pts) or Xience V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned.

All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or 2 months (including QCA/OCT investigation), 3 months, 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.

Clinical Study Identifier: NCT02747329

Contact Investigators or Research Sites near you

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Yundai Chen, Ph.D.

The PLA General Hospital
BeiJing, China

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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