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Vision II: Evaluation of GALILEO Intravascular Radiotherapy System

This study has been completed.
Information provided by:
Abbott Vascular Identifier:
First received: September 15, 2005
Last updated: July 31, 2008
Last verified: July 2008
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All adverse cardiac or extra cardiac events [ Time Frame: 24-month ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts 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…
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180583

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

Responsible Party: Matt Kiely, Abbott Vascular Identifier: NCT00180583     History of Changes
Other Study ID Numbers: Vision II v. 1.1 07/02/2002 
Study First Received: September 15, 2005
Last Updated: July 31, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on October 27, 2016