NCT01510509

The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients

TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Hospital Universitario Infanta Cristina · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	Titanium bare metal stent (Titan2®)	Titan2®, Hexacath, Paris, France
DEVICE	Everolimus Drug Eluting Stent (Xience-V®)	Xience-V®, Abbott Vascular, Santa Clara, California, USA

Timeline

• Start date: 2009-01-01
• First posted: 2012-01-16
• Last updated: 2012-01-16

Locations

8 sites across 2 countries: Finland, Spain