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

Diabetes Mellitus Clinical Trial

— TITANIC-XV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01510509
• Other study ID #: TITANIC-XV
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 11, 2012
• Last updated: January 13, 2012
• Start date: January 2009

Study information

• Verified date: December 2008
• Source: Hospital Universitario Infanta Cristina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Percutaneous Coronary Intervention

Intervention

Device:
• Titanium bare metal stent (Titan2®)
Titan2®, Hexacath, Paris, France
• Everolimus Drug Eluting Stent (Xience-V®)
Xience-V®, Abbott Vascular, Santa Clara, California, USA

Locations

Country	Name	City	State
Finland	Heart Center, Satakunta Hospital, Pori, Finland	Satakunta	Pori
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Hospital Juan Ramón Jiménez de Huelva	Huelva
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Puerto Real de Cádiz	Puerto Real	Cadiz
Spain	Hospital Virgen de la Salud de Toledo	Toledo
Spain	Hospital de Torrevieja	Torrevieja	Alicante
Spain	Hospital General Universitario de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Infanta Cristina

Countries where clinical trial is conducted

Finland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		No
Secondary	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.		No