NCT01510509

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.

Trial Health

60
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
Last Updated

January 16, 2012

Status Verified

December 1, 2008

First QC Date

January 11, 2012

Last Update Submit

January 13, 2012

Conditions

Diabetes MellitusPercutaneous Coronary Intervention

Keywords

Drug Eluting StentBioactive Bare Metal Stent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Late luminal loss

Study Arms (2)

Titanium bare metal stent

EXPERIMENTAL

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

Device: Titanium bare metal stent (Titan2®)

Everolimus Drug Eluting Stent

EXPERIMENTAL

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

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

Interventions

Titanium bare metal stent (Titan2®)DEVICE

Titan2®, Hexacath, Paris, France

Titanium bare metal stent
Everolimus Drug Eluting Stent (Xience-V®)DEVICE

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

Everolimus Drug Eluting Stent

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Heart Center, Satakunta Hospital, Pori, Finland

Satakunta, Pori, 28500, Finland

Location

Hospital de Torrevieja

Torrevieja, Alicante, 03180, Spain

Location

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, 06006, Spain

Location

Hospital Puerto Real de Cádiz

Puerto Real, Cadiz, 11510, Spain

Location

Hospital Juan Ramón Jiménez de Huelva

Huelva, Huelva, 21005, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Virgen de la Salud de Toledo

Toledo, Toledo, 45004, Spain

Location

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jose Ramon Lopez-Minguez, MD

    Hospital Universitario Infanta Cristina (Badajoz, Spain). Interventional Cardiology Department.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Chief of Interventional Cardiology Deparment

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 16, 2012

Study Start

January 1, 2009

Last Updated

January 16, 2012

Record last verified: 2008-12

Locations

ES(7)FI(1)