Trial Comparing Different Medical Devices for Infragenual Dilatation

University Hospital, Ghent35 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetic Angiopathies Intermittent Claudication

Interventions

Infragenual dilatationPROCEDURE

Infragenual dilatation

Infragenual dilatation with stentingPROCEDURE

Infragenual dilatation with stenting

Infragenual dilatation with cutting balloonPROCEDURE

Infragenual dilatation with cutting balloon

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Ghent

Ghent, Belgium

Outcomes

Primary Outcomes

Primary patency after 6 months

Time frame: After 6 months

Secondary Outcomes

Proving the superiority or non-superiority of one treatment procedure to another treatment procedure

Time frame: After 6 months.

Data from ClinicalTrials.gov

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