Clinical trial NCT01510509: The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients
Official title: TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Percutaneous Coronary Intervention
Keywords: Drug Eluting Stent
Bioactive Bare Metal Stent
Lead sponsor: Hospital Universitario Infanta Cristina
Sponsor class: OTHER
First posted: 2012-01-16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac events
Secondary outcomes:
measure: Late luminal loss
Other outcomes:
Locations:
city: Satakunta
country: Finland
facility: Heart Center, Satakunta Hospital, Pori, Finland
state: Pori
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Puerto Real
country: Spain
facility: Hospital Puerto Real de Cádiz
state: Cadiz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez de Huelva
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud de Toledo
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
Study officials:
affiliation: Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.
name: Jose Ramon Lopez-Minguez, MD
role: PRINCIPAL_INVESTIGATOR
References: