Coronary Artery Disease Clinical Trial
Official title:
The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario
The TWENTE Study is a single center prospective single-blinded randomized study. Randomization will involve the type of Drug-Eluting Stent (DES) used in study population. Patients will be blinded to the type of DES they will receive. The general practitioner of the patient will be requested not to disclose this information to the patient. Analysts who perform the data analyses will be blinded to the type DES used as well.
Primary research questions
To investigate whether the clinical outcome following the randomized implantation of the
Endeavor Resolute® versus XIENCE V® drug-eluting stent is similar, as assessed in a
non-inferiority setting by comparing target-vessel failure (TVF) of both stents. We want to
compare for both drug-eluting stents the combined endpoint of death, myocardial infarction
or revascularization related to the target-vessel, as well as death or myocardial infarction
that cannot be related to a significant flow obstruction in another vessel or to another
cause. According to current literature, non-inferiority of Endeavor resolute ® and XIENCE V®
is expected. But the non-inferiority of Endeavor resolute and XIENCE V® is not tested in a
controlled randomized trial yet.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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