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

University Hospital, Ghent1 site in 1 country35 target enrollmentSeptember 2004

ConditionsDiabetic Angiopathies Intermittent Claudication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Angiopathies
Sponsor: University Hospital, Ghent
Enrollment: 35
Locations: 1
Primary Endpoint: Primary patency after 6 months
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

April 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

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)