NCT00134277

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetic Angiopathies
• Intermittent Claudication

Interventions

Type	Name	Description
PROCEDURE	Infragenual dilatation	Infragenual dilatation
PROCEDURE	Infragenual dilatation with stenting	Infragenual dilatation with stenting
PROCEDURE	Infragenual dilatation with cutting balloon	Infragenual dilatation with cutting balloon
PROCEDURE	Laser therapy	Laser therapy

Timeline

• Start date: 2004-09-01
• Primary completion: 2009-01-01
• Completion: 2010-04-01
• First posted: 2005-08-24
• Last updated: 2011-09-09

Locations

1 site across 1 country: Belgium