Status:
COMPLETED
Trial Comparing Different Medical Devices for Infragenual Dilatation
Lead Sponsor:
University Hospital, Ghent
Conditions:
Diabetic Angiopathies
Intermittent Claudication
Eligibility:
All Genders
Phase:
NA
Brief Summary
This study is a comparison of different medical devices for infragenual dilatation.
Detailed Description
Dilatation and recanalisation of the distal veins (infragenual popliteal artery, tibiofibular trunc, posterior tibial artery, anterior tibial artery) by classical balloon dilatation or cutting balloon...
Eligibility Criteria
Inclusion
- Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00134277
Start Date
September 1 2004
End Date
April 1 2010
Last Update
September 9 2011
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000