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GISSOC II: Sirolimus Eluting Stent Versus Bare Metal Stent in Chronic Total Coronary Occlusions

NCT00220558 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-12-04

No results posted yet for this study

Summary

The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (CTO). The primary hypothesis is that, at 8-month follow-up, the minimal luminal diameter (MLD) of the coronary segment treated with stent implantation in CTO lesions is significantly larger with the use of SES compared to BMS. The treated segment is defined as the segment covered by the stent(s) plus 5 mm proximally and distally to the stent(s).

Conditions

Interventions

DEVICE

Coronary placement of bare metal stent vs. drug eluting stent

Sponsors & Collaborators

  • Cordis Italy a division of Johnson & Johnson Medical SpA

    collaborator UNKNOWN

  • Società Italiana di Cardiologia Invasiva

    lead OTHER

Principal Investigators

  • Paolo Rubartelli, MD · Azienda Ospedaliera Villa Scassi - Genoa - Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2007-10-31
Completion
2010-02-28

Countries

  • Italy

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 NCT00220558 on ClinicalTrials.gov