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CompletedNCT00180583Updated Aug 1, 2008

Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

A Phase 4 interventional study of Guidant GALILEO Intravascular Radiotherapy System in Coronary Artery Disease, sponsored by Abbott Medical Devices. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-01.

Sponsored by Abbott Medical Devices · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
268
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 268 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Vessel with extremely tortuous proximal segment, lesion with angulous segments (>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc...
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
268 participants (actual)

Study arms

  • Experimental
    1

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

    Device: Guidant GALILEO Intravascular Radiotherapy System

Interventions

  • DeviceGuidant GALILEO Intravascular Radiotherapy System

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

06

What researchers measure

Primary outcomes

  1. MACE

    Time frame: 6 months

Secondary outcomes

  1. All adverse cardiac or extra cardiac events

    Time frame: 24-month

07

Study locations

1 site
  • Clinique St. Hilaire
    Rouen, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00180583
Lead sponsor
Abbott Medical Devices
First posted
Sep 16, 2005
Start date
Feb 2002
Primary completion
Jul 2005
Completion
Jul 2005
Last update
Aug 1, 2008

Study contacts

Jacques BERLAND, MD
principal investigator · Clinique St Hilaire, Rouen, France
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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