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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

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.

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Detailed Description

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Conditions

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Diabetes Mellitus Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Titanium bare metal stent

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

Group Type EXPERIMENTAL

Titanium bare metal stent (Titan2®)

Intervention Type DEVICE

Titan2®, Hexacath, Paris, France

Everolimus Drug Eluting Stent

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

Group Type EXPERIMENTAL

Everolimus Drug Eluting Stent (Xience-V®)

Intervention Type DEVICE

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

Interventions

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Titanium bare metal stent (Titan2®)

Titan2®, Hexacath, Paris, France

Intervention Type DEVICE

Everolimus Drug Eluting Stent (Xience-V®)

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No