Exercise versus angioplasty for claudication based on iliac artery lesio

Conditions: Fontaine II
peripheral arterial disease
10003184
10003216

Registration Number: NL-OMON31237

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 230

Inclusion Criteria

- Age * 18 years
- Disabling claudication as defined by surgeon in discussion with the patient.
- Hemodynamic stenosis of the common or external iliac artery on duplex scanning (PSV ratio * 2.5 or EDV * 0.6 cm/s) or on MRA (> 50% stenosis) or occlusion of the common or external iliac artery on duplex scanning (PSV 0 m/s) or on MRA
- Lesion classified A, B or C according to the TASC classification of aorto-iliac lesions

Exclusion Criteria

- Life expectancy < 3 months
- Unable to fill-in self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc).
- Legally incompetent adults
- Known contrast allergy
- Pregnancy
- Contra-indication for anticoagulant therapy
- Duration of current complaints < 3 months
- Occlusion of the common femoral artery at the affected side

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is to assess the treatment outcomes of percutaneous<br /><br>revascularization and exercise therapy in terms of mobility parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective of this study is the level of functional status and<br /><br>health-related quality of life in patients with disabling intermittent<br /><br>claudication due to an iliac artery lesion after exercise training or<br /><br>percutaneous revascularization.</p><br>