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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Hospital Universitario Infanta Cristina.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jose Ramon Lopez Minguez, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier:
NCT01510509
First received: January 11, 2012
Last updated: January 13, 2012
Last verified: December 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Infanta Cristina:

Primary Outcome Measures:
  • Major adverse cardiac events [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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.


Study Start Date: January 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510509

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

No publications provided

Responsible Party: Jose Ramon Lopez Minguez, MD, PhD, Chief of Interventional Cardiology Deparment, Hospital Universitario Infanta Cristina
ClinicalTrials.gov Identifier: NCT01510509     History of Changes
Other Study ID Numbers: TITANIC-XV
Study First Received: January 11, 2012
Last Updated: January 13, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitario Infanta Cristina:
Drug Eluting Stent
Bioactive Bare Metal Stent

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014