Invasive Revascularization or Not in Intermittent Claudication (IRONIC)

Sahlgrenska University Hospital

Status: Completed

Conditions: Intermittent Claudication

Treatments: Other: Best medical treatment (BMT); Procedure: INVASIVE (INV) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01219842

Sahlgrenska Academy

Details and patient eligibility

About

Peripheral arterial disease (PAD) often causes exertion pain in the legs, intermittent claudication (CI) affecting> 10% of individuals> 65 years. A recent Swedish Health Technology Assessment Report identified only limited evidence for the effectiveness of invasive treatment for IC in patients already on exercise training. The prognosis for the extremity is usually benign and treatment therefore aims at improving quality of life. Invasive treatment can also cause serious complications. Coronary artery disease is common in IC patients increasing the risk with invasive treatment. In spite of these uncertain merits and potential risks, invasive procedures for IC are increasing and 37% of all invasive procedures for PAD in Sweden are performed for IC. The aim of this study is to evaluate the additional effects of modern invasive treatment in patients with intermittent claudication receiving modern best medical treatment (BMT). The primary hypothesis in the study is that invasive treatment in addition to BMT improves health related quality of life and walking performance compared to BMT only.

Enrollment: 159 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with intermittent claudication (typical symptoms and ABI <0.9) seeking treatment
• Significant aortoiliac- and/or femoropopliteal lesion.
• Age 30-80 years

Exclusion criteria

• Invasive treatment contraindicated because of severe intercurrent disease.
• Two or more failed vascular reconstructions in the same leg.
• Employees unable to work because of intermittent claudication.
• Need for open reconstruction below the tibioperoneal trunc.
• Thromboembolic etiology (popliteal artery aneurysm; cardiac emboli)
• Other disease severely affecting walking performance.
• Body weight > 120 kilograms.
• Age <30 or > 80 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

INVASIVE (INV) group

Active Comparator group

Description:

Modern endovascular and/or open revascularization according to the recommendations in the TASC II document.

Treatment:

Other: Best medical treatment (BMT)

Procedure: INVASIVE (INV) treatment

NON-INVASIVE (NON) group

Active Comparator group

Description:

Patients receiving only best medical treatment (BMT).

Treatment:

Other: Best medical treatment (BMT)