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A Trial of Bare Metal Stent - Cobalt Chromium Versus Stent Coating With Sirolimus

NCT01093391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-07-22

No results posted yet for this study

Summary

The objective of this study is to evaluate the security issues and efficacy of coronary stenting Cobalt Chrome covered with sirolimus-eluting Cobalt Chrome platform in patients with coronary artery lesion.

Conditions

Interventions

DEVICE

DRUG ELUTING STENT

Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

DEVICE

BARE METAL STENT

Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.

Sponsors & Collaborators

  • Scitech Produtos Medicos Ltda

    lead INDUSTRY

Principal Investigators

  • Expedito E. Ribeiro da Silva, Medicine · Instituto do Coração do Hospital das Clínicas da Fac. de Medicina da USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Brazil

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 NCT01093391 on ClinicalTrials.gov