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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Percutaneous Coronary Intervention

Intervention / Treatment
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* Device: Titanium bare metal stent (Titan2®)
* Device: Everolimus Drug Eluting Stent (Xience-V®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Titanium bare metal stent<br>Titanium bare metal stent (Titan2®, Hexacath, Paris, France) | Device: Titanium bare metal stent (Titan2®)<br>* Titan2®, Hexacath, Paris, France<br>|
| Experimental: Everolimus Drug Eluting Stent<br>Xience-V®, Abbott Vascular, Santa Clara, California, USA | Device: Everolimus Drug Eluting Stent (Xience-V®)<br>* Xience-V®, Abbott Vascular, Santa Clara, California, USA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Eluting Stent, Bioactive Bare Metal Stent