Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, percutaneous coronary intervention
Treatments titanium bare metal stent (titan2®), everolimus drug eluting stent (xience-v®)
Phase phase 4
Sponsor Hospital Universitario Infanta Cristina
Start date January 2009
Trial identifier NCT01510509, TITANIC-XV

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Titanium bare metal stent (Titan2®, Hexacath, Paris, France)
titanium bare metal stent (titan2®)
Titan2®, Hexacath, Paris, France
(Experimental)
Xience-V®, Abbott Vascular, Santa Clara, California, USA
everolimus drug eluting stent (xience-v®)
Xience-V®, Abbott Vascular, Santa Clara, California, USA

Primary Outcomes

Measure
Major adverse cardiac events
time frame:

Secondary Outcomes

Measure
Late luminal loss
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
Principal investigator Jose Ramon Lopez-Minguez, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2012.
Information provided to ClinicalTrials.gov by Hospital Universitario Infanta Cristina.