Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

Abbott Medical Devices268 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

268

Conditions

Coronary Artery Disease

Interventions

Guidant GALILEO Intravascular Radiotherapy SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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…

Locations (1)

Clinique St. Hilaire

Rouen, France

Outcomes

Primary Outcomes

MACE

Time frame: 6 months

Secondary Outcomes

All adverse cardiac or extra cardiac events

Time frame: 24-month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.