Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
Phase 4
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00180583
- Lead Sponsor
- Abbott Medical Devices
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 268
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...
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method MACE 6 months
- Secondary Outcome Measures
Name Time Method All adverse cardiac or extra cardiac events 24-month
Trial Locations
- Locations (1)
Clinique St. Hilaire
🇫🇷Rouen, France
Clinique St. Hilaire🇫🇷Rouen, France