Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
July 31, 2008 updated by: Abbott Medical Devices
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
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
268
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rouen, France
- Clinique St. Hilaire
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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…
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
|
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
MACE
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
All adverse cardiac or extra cardiac events
Time Frame: 24-month
|
24-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jacques BERLAND, MD, Clinique St Hilaire, Rouen, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2002
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 15, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
August 1, 2008
Last Update Submitted That Met QC Criteria
July 31, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vision II v. 1.1 07/02/2002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.