Invasive Revascularization or Not in Intermittent Claudication

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.

Conditions

• Intermittent Claudication

Interventions

PROCEDURE

INVASIVE (INV) treatment

Modern endovascular and/or open revascularisation according to the TASC II recommendations.

OTHER

Best medical treatment (BMT)

Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.

Sponsors & Collaborators

• Göteborg University

  collaborator OTHER

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Joakim Nordanstig, M D · Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

• Lennart Jivegård, M D, PhD · Sahlgrenska Academy, Institute of Medicine, department of Molecular and Clinical Medicine

• Klas Österberg, M D, PhD · Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

• Johan Millinger, MD · Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2014-12-31

Completion

2020-06-30

Countries

• Sweden

Study Locations