Trial Comparing Different Medical Devices for Infragenual Dilatation

Not Applicable

Completed

• Conditions: Intermittent Claudication; Diabetic Angiopathies
• Interventions: Procedure: Infragenual dilatation with stenting; Procedure: Infragenual dilatation with cutting balloon; Procedure: Laser therapy; Procedure: Infragenual dilatation

• 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).

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Primary Completion: 2009-01
• Study Completion: 2010-04
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09

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

Arm && Interventions

Group	Intervention	Description
Infragenual dilatation with stenting	Infragenual dilatation with stenting	-
Infragenual dilatation with cutting balloon	Infragenual dilatation with cutting balloon	-
Laser therapy	Laser therapy	-
Infragenual dilatation	Infragenual dilatation	-

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