Skip to main content
OpenTrials
Completed

NCT Number: NCT01219842

Invasive Revascularization or Not in Intermittent Claudication

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intermittent Claudication Cardiovascular Diseases Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INVASIVE (INV) treatment

Procedure

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

Best medical treatment (BMT)

Other

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

Primary outcomes

  1. Health Related Quality of Life (HRQOL)

    Time frame: 24 months with intermistic analysis at 12 months

    Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL

Secondary outcomes

  1. Walking performance on treadmill test

    Time frame: 24 months with interimistic analysis at 12 months

    Graded treadmill test with progressively increasing speed and inclination.

  2. Health Related Quality of Life (HRQOL)

    Time frame: 60 months

    Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL

  3. Walking performance on treadmill test

    Time frame: 60 months

    Graded treadmill test with progressively increasing speed and inclination.

  4. six-minutes walk test

    Time frame: 60 months

    Corridor-based walk test during six minutes walk

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Acronym: IRONIC

Important dates

Study start
2010
Primary completion
2014
Study completion
2020
First posted
Oct 13, 2010
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.