Status:
COMPLETED
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
Lead Sponsor:
Abbott Medical Devices
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system
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
Eligibility Criteria
Inclusion
- 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
- Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
268 Patients enrolled
Trial Details
Trial ID
NCT00180583
Start Date
February 1 2002
End Date
July 1 2005
Last Update
August 1 2008
Active Locations (1)
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1
Clinique St. Hilaire
Rouen, France