The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
- Conditions
- Diabetes MellitusPercutaneous Coronary Intervention
- Interventions
- Device: Titanium bare metal stent (Titan2®)Device: Everolimus Drug Eluting Stent (Xience-V®)
- Registration Number
- NCT01510509
- Lead Sponsor
- Hospital Universitario Infanta Cristina
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
- 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"
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Titanium bare metal stent Titanium bare metal stent (Titan2®) Titanium bare metal stent (Titan2®, Hexacath, Paris, France) Everolimus Drug Eluting Stent Everolimus Drug Eluting Stent (Xience-V®) Xience-V®, Abbott Vascular, Santa Clara, California, USA
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (8)
Hospital Puerto Real de Cádiz
🇪🇸Puerto Real, Cadiz, Spain
Hospital de Torrevieja
🇪🇸Torrevieja, Alicante, Spain
Hospital Virgen de la Salud de Toledo
🇪🇸Toledo, Spain
Heart Center, Satakunta Hospital, Pori, Finland
🇫🇮Satakunta, Pori, Finland
Hospital Universitario Infanta Cristina
🇪🇸Badajoz, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Juan Ramón Jiménez de Huelva
🇪🇸Huelva, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain