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

Hospital Universitario Infanta Cristina

Status and phase: Unknown; Phase 4

Conditions: Percutaneous Coronary Intervention; Diabetes Mellitus

Treatments: Device: Everolimus Drug Eluting Stent (Xience-V®); Device: Titanium bare metal stent (Titan2®)

Study type: Interventional

Funder types: Other

Identifiers

NCT01510509

TITANIC-XV

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Titanium bare metal stent

Experimental group

Description:

Titanium bare metal stent (Titan2®, Hexacath, Paris, France)

Treatment:

Device: Titanium bare metal stent (Titan2®)

Everolimus Drug Eluting Stent

Experimental group

Description:

Xience-V®, Abbott Vascular, Santa Clara, California, USA

Treatment:

Device: Everolimus Drug Eluting Stent (Xience-V®)