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

This study is a comparison of different medical devices for infragenual dilatation.

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).

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)