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Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180583
First Posted: September 16, 2005
Last Update Posted: August 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott Vascular
  Purpose
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system

Condition Intervention Phase
Coronary Artery Disease Device: Guidant GALILEO Intravascular Radiotherapy System Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • MACE [ Time Frame: 6 months ]

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

Enrollment: 268
Study Start Date: February 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

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 Submitted: September 15, 2005
First Posted: September 16, 2005
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