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Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

NCT ID: NCT00180583

Last Updated: 2008-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2005-07-31

Brief Summary

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To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

Detailed Description

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The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System

Group Type EXPERIMENTAL

Guidant GALILEO Intravascular Radiotherapy System

Intervention Type DEVICE

Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System

Interventions

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Guidant GALILEO Intravascular Radiotherapy System

Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient with angor, patients with only one de novo lesion. Target zone must be \< 52 mm, artery section must be \< 3,7mm and \> 2,25 mm

Exclusion Criteria

* Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Vascular

Principal Investigators

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Jacques BERLAND, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique St Hilaire, Rouen, France

Locations

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Clinique St. Hilaire

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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Vision II v. 1.1 07/02/2002

Identifier Type: -

Identifier Source: org_study_id