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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00134277

Enrollment

Registered

2005-08-24

Start date

2004-09-30

Completion date

2010-04-30

Last updated

2011-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Angiopathies, Intermittent Claudication

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).

Interventions

PROCEDUREInfragenual dilatation

Infragenual dilatation

PROCEDUREInfragenual dilatation with stenting

Infragenual dilatation with stenting

PROCEDUREInfragenual dilatation with cutting balloon

Infragenual dilatation with cutting balloon

PROCEDURELaser therapy

Laser therapy

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Primary patency after 6 months	After 6 months

Secondary

Measure	Time frame
Proving the superiority or non-superiority of one treatment procedure to another treatment procedure	After 6 months.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026