The Titan Versus Everolimus Intracoronary Stent (Xience V) in Diabetic Patients (TITANIC-XV)
TITANIC-XV Trial: Prospective, Multicenter and Randomized Trial (Bioactive Bare Metal Titanium Stent Versus Everolimus Drug Eluting Stent)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pori
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Satakunta, Pori, Finland, 28500
- Heart Center, Satakunta Hospital, Pori, Finland
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-
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Badajoz, Spain, 06006
- Hospital Universitario Infanta Cristina
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Huelva, Spain, 21005
- Hospital Juan Ramón Jiménez de Huelva
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Toledo, Spain, 45004
- Hospital Virgen de la Salud de Toledo
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Valencia, Spain, 46014
- Hospital General Universitario De Valencia
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Alicante
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Torrevieja, Alicante, Spain, 03180
- Hospital de Torrevieja
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Cadiz
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Puerto Real, Cadiz, Spain, 11510
- Hospital Puerto Real de Cádiz
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Madrid
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Majadahonda, Madrid, Spain, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Titanium bare metal stent
Titanium bare metal stent (Titan2®, Hexacath, Paris, France)
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Titan2®, Hexacath, Paris, France
|
|
Experimental: Everolimus Drug Eluting Stent
Xience-V®, Abbott Vascular, Santa Clara, California, USA
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Xience-V®, Abbott Vascular, Santa Clara, California, USA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
|---|---|
|
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
Outcome Measure |
Measure Description |
|---|---|
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jose Ramon Lopez-Minguez, MD, Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TITANIC-XV
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