Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

Abbott

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Guidant GALILEO Intravascular Radiotherapy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00180583

Vision II v. 1.1 07/02/2002

Details and patient eligibility

About

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

Full 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

Enrollment: 268 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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...

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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268 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Device: Guidant GALILEO Intravascular Radiotherapy System