Trial Comparing Different Medical Devices for Infragenual Dilatation
Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy
1 other identifier
interventional
35
1 country
1
Brief Summary
This study is a comparison of different medical devices for infragenual dilatation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedSeptember 9, 2011
September 1, 2011
4.3 years
August 23, 2005
September 8, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Primary patency after 6 months
After 6 months
Secondary Outcomes (1)
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure
After 6 months.
Study Arms (4)
Infragenual dilatation with stenting
ACTIVE COMPARATORInfragenual dilatation with cutting balloon
ACTIVE COMPARATORLaser therapy
ACTIVE COMPARATORInfragenual dilatation
PLACEBO COMPARATORInterventions
Infragenual dilatation with stenting
Infragenual dilatation with cutting balloon
Eligibility Criteria
You may qualify if:
- Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
You may not qualify if:
- Acute ischemia
- Multisegmentaric damage above the knee
- Sepsis: acute respiratory distress syndrome (ARDS), C-reactive protein (CRP) \> 30, white blood cell (WBC) \> 25,000
- Acute myocardial infarction (AMI) during the last 14 days
- Operative contraindication
- Life expectancy \< 2 years
- Blue toe syndrome (micro-embolisation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caren Randon, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 24, 2005
Study Start
September 1, 2004
Primary Completion
January 1, 2009
Study Completion
April 1, 2010
Last Updated
September 9, 2011
Record last verified: 2011-09