A Phase 4 interventional study of Titanium bare metal stent (Titan2®) and Everolimus Drug Eluting Stent (Xience-V®) in Diabetes Mellitus and Percutaneous Coronary Intervention, sponsored by Hospital Universitario Infanta Cristina. Status unknown at 8 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2012-01-16.
Sponsored by Hospital Universitario Infanta Cristina · Phase 4, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
Browse Diabetes Mellitus studies →Hospital Universitario Infanta Cristina is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Titanium bare metal stent (Titan2®, Hexacath, Paris, France)
Device: Titanium bare metal stent (Titan2®)
Xience-V®, Abbott Vascular, Santa Clara, California, USA
Device: Everolimus Drug Eluting Stent (Xience-V®)
Titan2®, Hexacath, Paris, France
Xience-V®, Abbott Vascular, Santa Clara, California, USA
Major adverse cardiac events
Comparison of major adverse cardiac events defined as death, non fatal myocardial infarction, brain stroke or new revascularization at 1, 6, 12 and 24 months follow-up between the two treatment strategies.
Late luminal loss
Comparison of late luminal loss within the in-segment zone at 9 months between the two treatment strategies in the subgroup of patients with angiographic follow-up.
This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Infanta Cristina