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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01510509

Acronym

TITANIC-XV

Enrollment

Unknown

Registered

2012-01-16

Start date

2009-01-31

Completion date

Unknown

Last updated

2012-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Percutaneous Coronary Intervention

Keywords

Drug Eluting Stent, Bioactive Bare Metal Stent

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.

Interventions

DEVICETitanium bare metal stent (Titan2®)

Titan2®, Hexacath, Paris, France

DEVICEEverolimus Drug Eluting Stent (Xience-V®)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	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

Measure	Time frame	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.

Countries

Finland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026