TITANIC-XV: The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients

Sponsor

Hospital Universitario Infanta Cristina (Other)

Overall Status

Unknown status

CT.gov ID

NCT01510509

Collaborator

(none)

Locations

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Percutaneous Coronary Intervention	Device: Titanium bare metal stent (Titan2®) Device: Everolimus Drug Eluting Stent (Xience-V®)	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Titanium bare metal stent

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

Device: Titanium bare metal stent (Titan2®)

Titan2®, Hexacath, Paris, France

Experimental: Everolimus Drug Eluting Stent

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

Device: Everolimus Drug Eluting Stent (Xience-V®)

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart Center, Satakunta Hospital, Pori, Finland	Satakunta	Pori	Finland	28500
2	Hospital de Torrevieja	Torrevieja	Alicante	Spain	03180
3	Hospital Puerto Real de Cádiz	Puerto Real	Cadiz	Spain	11510
4	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid	Spain	28222
5	Hospital Universitario Infanta Cristina	Badajoz		Spain	06006
6	Hospital Juan Ramón Jiménez de Huelva	Huelva		Spain	21005
7	Hospital Virgen de la Salud de Toledo	Toledo		Spain	45004
8	Hospital General Universitario de Valencia	Valencia		Spain	46014

Sponsors and Collaborators

Hospital Universitario Infanta Cristina

Investigators

Principal Investigator: Jose Ramon Lopez-Minguez, MD, Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jose Ramon Lopez Minguez, MD, PhD, Chief of Interventional Cardiology Deparment, Hospital Universitario Infanta Cristina

ClinicalTrials.gov Identifier:

NCT01510509

Other Study ID Numbers:

TITANIC-XV

First Posted:

Jan 16, 2012

Last Update Posted:

Jan 16, 2012

Last Verified:

Dec 1, 2008

Keywords provided by Jose Ramon Lopez Minguez, MD, PhD, Chief of Interventional Cardiology Deparment, Hospital Universitario Infanta Cristina

Drug Eluting Stent

Bioactive Bare Metal Stent

Additional relevant MeSH terms:

Everolimus

Study Results

No Results Posted as of Jan 16, 2012