Coronary Artery Disease Clinical Trial
Official title:
A Randomized Controlled Trial of the Resolute Zotarolimus-Eluting Stent Versus the Taxus Liberte Paclitaxel-Eluting Stent for Percutaneous Coronary Intervention in a Real-World All-comer Patient Population in China
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9 months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer patient population requiring stent implantation.
This study is a prospective, multicenter, randomized, two-arm, open-label study, designed to
assess the non-inferiority of Resolute stent compared to Taxus Liberte stent in in-stent late
lumen loss.
The primary objective of this study is to evaluate the in-stent late lumen loss (LLL) at 9
months, defined as the difference between the post-procedure minimal lumen diameter (MLD) and
the follow-up angiography MLD, of the Resolute Zotarolimus-Eluting Coronary Stent System
compared to Taxus Liberte Paclitaxel-Eluting Coronary Stent System in a real-world all-comer
patient population requiring stent implantation.
This trial will be conducted at approximately 20 sites and will enroll up to 400 subjects,
randomized to the Resolute stent and Taxus Liberte stent in a 1:1 ratio. Subjects will be
randomized using an interactive voice response system (IVRS).
Due to the design characteristics of the devices, the study investigators and operators can
not be blinded. However, the clinical event adjudication committee, consisting of
cardiologists who are not participating in the study, will be blinded for the treatment arm
of the subjects to avoid a potential bias in the adjudication process of events.
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