Clinical Trial: Trial Comparing Different Medical Devices for Infragenual Dilatation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomised Comparing Trial Between an Infragenual Dilatation (ID), an ID With Stenting, an ID With Cutting Balloon and Laser Therapy

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

Detailed Summary: 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).
Sponsor: University Hospital, Ghent

Current Primary Outcome: Primary patency after 6 months [ Time Frame: After 6 months ]

Original Primary Outcome: Primary patence after 6 months

Current Secondary Outcome: Proving the superiority or non-superiority of one treatment procedure to another treatment procedure [ Time Frame: After 6 months. ]

Original Secondary Outcome: Proving the superiority or non-superiority of one treatment procedure to another treatment procedure.

Information By: University Hospital, Ghent

Dates:
Date Received: August 23, 2005
Date Started: September 2004
Date Completion:
Last Updated: September 8, 2011
Last Verified: September 2011