NCT00180583

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Feb 2002

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

August 1, 2008

Status Verified

July 1, 2008

Enrollment Period

3.4 years

First QC Date

September 15, 2005

Last Update Submit

July 31, 2008

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • MACE

    6 months

Secondary Outcomes (1)

  • All adverse cardiac or extra cardiac events

    24-month

Study Arms (1)

1

EXPERIMENTAL

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

Device: Guidant GALILEO Intravascular Radiotherapy System

Interventions

Guidant GALILEO Intravascular Radiotherapy SystemDEVICE

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique St. Hilaire

Rouen, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jacques BERLAND, MD

    Clinique St Hilaire, Rouen, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 16, 2005

Study Start

February 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

August 1, 2008

Record last verified: 2008-07

Locations

FR(1)