Trial Comparing Different Medical Devices for Infragenual Dilatation

Ghent University Hospital (UZ)

Status: Completed

Conditions: Diabetic Angiopathies; Intermittent Claudication

Treatments: Procedure: Infragenual dilatation; Procedure: Laser therapy; Procedure: Infragenual dilatation with cutting balloon; Procedure: Infragenual dilatation with stenting

Study type: Interventional

Funder types: Other

Identifiers

NCT00134277

2004/161

Details and patient eligibility

About

This study is a comparison of different medical devices for infragenual dilatation.

Full 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).

Enrollment: 35 patients

Sex: All

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 4 patient groups, including a placebo group

Infragenual dilatation with stenting

Active Comparator group

Treatment:

Procedure: Infragenual dilatation with stenting

Infragenual dilatation with cutting balloon

Active Comparator group

Treatment:

Procedure: Infragenual dilatation with cutting balloon

Laser therapy

Active Comparator group

Treatment:

Procedure: Laser therapy

Infragenual dilatation

Placebo Comparator group

Treatment:

Procedure: Infragenual dilatation