Exercise versus angioplasty for claudication based on iliac artery lesion

Exercise versus angioplasty for claudication based on iliac artery lesion - EVACIA-study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31237

Enrollment

230

Registered

2007-09-06

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Fontaine II peripheral arterial disease

Interventions

One group (115 patients) will get percutaneous revascularization. One group (115 patients) will get supervised exercise training. All patients will get optimal medical treatment.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Life expectancy

Design outcomes

Primary

Measure	Time frame
Primary endpoint is to assess the treatment outcomes of percutaneous revascularization and exercise therapy in terms of mobility parameters.	—

Secondary

Measure	Time frame
Secondary objective of this study is the level of functional status and health-related quality of life in patients with disabling intermittent claudication due to an iliac artery lesion after exercise training or percutaneous revascularization.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)