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The Optical Coherence Tomography Drug Eluting Stent Investigation

NCT00776204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-03-01

No results posted yet for this study

Summary

The objective of this study is to evaluate the completeness of struts coverage and vessel wall response to the new generation JACTAX drug-eluting stent vs Taxus stent in de novo coronary artery lesions at 6 months post index procedure. To investigate the completeness of the coverage as well as the number of uncovered stent struts per section, high resolution (\~ 10-15 µm axial) intracoronary Optical Coherence Tomography (OCT) will be used.

Conditions

Interventions

DEVICE

JACTAX Drug eluting stent

Jactax stent placed in coronary artery

DEVICE

JACTAX LD drug eluting stent

JACTAX LD stent placed in coronary artery

DEVICE

Taxus Libertè

Taxus Libertè stent placed in coronary artery

Sponsors & Collaborators

  • Labcoat, Ltd.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Giulio Guagliumi, MD · Cardiovascular Department Ospedali Riuniti di Bergamo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-07-31
Completion
2011-02-28

Countries

  • Italy

Study Locations

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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 NCT00776204 on ClinicalTrials.gov