The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
This trial is active, not recruiting.
|Conditions||diabetes mellitus, percutaneous coronary intervention|
|Treatments||titanium bare metal stent (titan2®), everolimus drug eluting stent (xience-v®)|
|Sponsor||Hospital Universitario Infanta Cristina|
|Start date||January 2009|
|Trial identifier||NCT01510509, TITANIC-XV|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Satakunta, Finland||Heart Center, Satakunta Hospital, Pori, Finland||no longer recruiting|
|Torrevieja, Spain||Hospital de Torrevieja||no longer recruiting|
|Puerto Real, Spain||Hospital Puerto Real de Cádiz||no longer recruiting|
|Majadahonda, Spain||Hospital Universitario Puerta de Hierro Majadahonda||no longer recruiting|
|Badajoz, Spain||Hospital Universitario Infanta Cristina||no longer recruiting|
|Huelva, Spain||Hospital Juan Ramón Jiménez de Huelva||no longer recruiting|
|Toledo, Spain||Hospital Virgen de la Salud de Toledo||no longer recruiting|
|Valencia, Spain||Hospital General Universitario de Valencia||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Major adverse cardiac events
Late luminal loss
Male or female participants from 18 years up to 85 years old.
Inclusion Criteria: - Age over 18 years - Diabetes mellitus according to the World Health Organization Report - Percutaneous coronary intervention due to at least one significant de novo lesion (defined as at least 50% diameter stenosis by visual estimation) in a native coronary artery or coronary bypass graft. - Informed Consent "signed" Exclusion Criteria: - Inclusion in another clinical research protocol - Pregnancy - STEMI within 48 hours - Unprotected left main disease - Restenotic lesions - Stent diameter < 2,5 mm or > 3,5 mm - Stent length more than 28 mm in < 3 mm vessels - Chronic total occlusions - Allergy to aspirin, clopidogrel, heparin or abciximab - Active bleeding or a significant increase in bleeding risk - Significant renal insufficiency defined as creatinine > 2 mg/dl - Severely depressed LV function (EF≤35%) - Cardiogenic shock - Ischemic stroke within the last 6 months - Contraindication for DES - Disease with life expectancy < 12 months
|Official title||TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)|
|Principal investigator||Jose Ramon Lopez-Minguez, MD|
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