Trial Comparing Different Medical Devices for Infragenual Dilatation
Not Applicable
Completed
- Conditions
- Intermittent ClaudicationDiabetic Angiopathies
- Registration Number
- NCT00134277
- Lead Sponsor
- University Hospital, Ghent
- 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 with or without stenting or by endovascular laser. This intervention happens only once; the duration of the intervention depends on the procedure and the original injuries(30 - 120 minutes).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
- Diabetes type I or II with diabetic angiopathy stage IIb to IV (Fontaine)
- Atherosclerotic patients with distal angiopathy stage IIb to IV (Fontaine)
Exclusion Criteria
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary patency after 6 months After 6 months
- Secondary Outcome Measures
Name Time Method Proving the superiority or non-superiority of one treatment procedure to another treatment procedure After 6 months.
Trial Locations
- Locations (1)
University Hospital Ghent
🇧🇪Ghent, Belgium
University Hospital Ghent🇧🇪Ghent, Belgium