Coronary Artery Disease
Conditions
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
Interventions
DEVICEGuidant GALILEO Intravascular Radiotherapy System
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| All adverse cardiac or extra cardiac events | 24-month |
Countries
France
Outcome results
None listed