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Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

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ClinicalTrials.gov Identifier: NCT00180583
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 1, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Guidant GALILEO Intravascular Radiotherapy System Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis
Study Start Date : February 2002
Primary Completion Date : July 2005
Study Completion Date : July 2005
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
Device: Guidant GALILEO Intravascular Radiotherapy System
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System


Outcome Measures

Primary Outcome Measures :
  1. MACE [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. All adverse cardiac or extra cardiac events [ Time Frame: 24-month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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…
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180583


Locations
France
Clinique St. Hilaire
Rouen, France
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Jacques BERLAND, MD Clinique St Hilaire, Rouen, France
More Information

Responsible Party: Matt Kiely, Abbott Vascular
ClinicalTrials.gov Identifier: NCT00180583     History of Changes
Other Study ID Numbers: Vision II v. 1.1 07/02/2002
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 1, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases