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

January 13, 2012 updated by: Jose Ramon Lopez Minguez, Hospital Universitario Infanta Cristina

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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Pori
      • Satakunta, Pori, Finland, 28500
        • Heart Center, Satakunta Hospital, Pori, Finland
  • Spain
      • Badajoz, Spain, 06006
        • Hospital Universitario Infanta Cristina
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jiménez de Huelva
      • Toledo, Spain, 45004
        • Hospital Virgen de la Salud de Toledo
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Alicante
      • Torrevieja, Alicante, Spain, 03180
        • Hospital de Torrevieja
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Puerto Real de Cádiz
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Infanta Cristina

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 13, 2012

First Posted (Estimate)

January 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 13, 2012

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TITANIC-XV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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