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

NCT01510509 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2012-01-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Titanium bare metal stent (Titan2®)

Titan2®, Hexacath, Paris, France

DEVICE

Everolimus Drug Eluting Stent (Xience-V®)

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

Sponsors & Collaborators

  • Hospital Universitario Infanta Cristina

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31

Countries

  • Finland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510509 on ClinicalTrials.gov