Invasive Revascularization or Not in Intermittent Claudication

Study Overview
=================
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.

Official Title
-----------------
Invasive Revascularization or Not in Intermittent Claudication

Conditions
-----------------
Intermittent Claudication

Intervention / Treatment
-----------------
* Procedure: INVASIVE (INV) treatment
* Other: Best medical treatment (BMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: INVASIVE (INV) group<br>Modern endovascular and/or open revascularization according to the recommendations in the TASC II document. | Procedure: INVASIVE (INV) treatment<br>* Modern endovascular and/or open revascularisation according to the TASC II recommendations.<br>Other: Best medical treatment (BMT)<br>* Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.<br>|
| Active Comparator: NON-INVASIVE (NON) group<br>Patients receiving only best medical treatment (BMT). | Other: Best medical treatment (BMT)<br>* Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life (HRQOL) | Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL | 24 months with intermistic analysis at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking performance on treadmill test | Graded treadmill test with progressively increasing speed and inclination. | 24 months with interimistic analysis at 12 months | 
| Health Related Quality of Life (HRQOL) | Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL | 60 months | 
| Walking performance on treadmill test | Graded treadmill test with progressively increasing speed and inclination. | 60 months | 
| six-minutes walk test | Corridor-based walk test during six minutes walk | 60 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity