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Brazilian and Italian Evaluation of Safety Using Tacrolimus-eluting Stent With Short-term Dual Antiplatelet Regimen

NCT01122719 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-05-07

No results posted yet for this study

Summary

To evaluate the safety and efficacy of the Janus OPTIMA Tacrolimus-Eluting Stent (Optima TES, CID) for the treatment of de novo coronary lesions when associated with short-term (two months) dual antiplatelet (aspirin + clopidogrel) regimen.

Conditions

  • Stable Coronary Disease
  • Unstable Coronary Disease
  • Documented Silent Ischemia

Interventions

DEVICE

Drug Eluting Stent

Sponsors & Collaborators

  • Contract research Organization: Cardiovascular Research Center - Sao Paulo, Brazil

    collaborator UNKNOWN

  • CID - Carbostent & Implantable Devices

    lead INDUSTRY

Principal Investigators

  • Marco Valgimigli, Dr · Azienda Ospedaliero Universitaria di Ferrara - Italy

  • Alexandre Abizaid, Dr · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30
Completion
2013-03-31

Countries

  • Brazil
  • Italy

Study Locations

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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 NCT01122719 on ClinicalTrials.gov