MedTrace Logo

A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent

NCT00825279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2010-05-28

No results posted yet for this study

Summary

The success of stent implantation has led to the increasingly widespread use of them in the treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation of stents with improved coating materials and the development of polymers that release different kinds of drugs that prevent the activation and/or proliferation of smooth muscle cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this matter. The new generation of stents with biodegradable polymers and short time of drug release gives new advantages to this therapeutic, multiple studies and registries challenge this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).

For this reason the present study aims to compare a stainless steel stent with a drug eluting stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.

Conditions

Interventions

DEVICE

Bare Metal Stent

Stainless steel stent

DEVICE

Drug Eluting Stent

stent coated with the biodegradable polymer matrix hemoparin and paclitaxel

Sponsors & Collaborators

  • Eucatech AG

    collaborator INDUSTRY

  • Centro de estudios en Cardiologia Intervencionista

    lead OTHER

Principal Investigators

  • Alfredo E Rodriguez, MD, PHD · Centro de estudios en Cardiologia Intervencionista

  • Carlos Fernandez-Pereira, MD · Centro de estudios en Cardiologia Intervencionista

  • Alfredo E Rodriguez, MD, PHD · Centro de Estudios en Cardiologia Internvencionista

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Argentina

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 NCT00825279 on ClinicalTrials.gov