Intermittent Claudication
Conditions
Keywords
Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity
Brief summary
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.
Interventions
PROCEDUREINVASIVE (INV) treatment
Modern endovascular and/or open revascularisation according to the TASC II recommendations.
Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.
Sponsors
Göteborg University
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQOL) | 24 months with intermistic analysis at 12 months | Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Walking performance on treadmill test | 24 months with interimistic analysis at 12 months | Graded treadmill test with progressively increasing speed and inclination. |
| Health Related Quality of Life (HRQOL) | 60 months | Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL |
| six-minutes walk test | 60 months | Corridor-based walk test during six minutes walk |
Countries
Sweden
Outcome results
None listed