Diabetes Mellitus Clinical Trial
Official title:
TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
Even though the safety of drug eluting stents has been long established, in roughly 25% o
patients their implantation is not considered, for specifically clinical reasons (chronic
anticoagulation, bleeding, etc…), which make prolonged use of clopidogrel unsuitable. A
considerable percentage of these patients have diabetes mellitus, a well known risk factor
for stent thrombosis. Recently, the special characteristics of the titanium stent with
nitric oxide have been described, causing it to be considered as a bioactive stent.
The TITANIC-XV trial was a prospective randomized multi-center active-treatment-controlled
clinical trial, with the chief aim to evaluate clinical outcome after titanium bare metal
stent (Titan2®, Hexacath, Paris, France) implantation as compared with everolimus drug
eluting stent (Xience-V®, Abbott Vascular, Santa Clara, California, USA) in diabetic
patients undergoing percutaneous coronary intervention.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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