Invasive Revascularization or Not in Intermittent Claudication (IRONIC)

March 17, 2021 updated by: Joakim Nordanstig, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: INVASIVE (INV) group
Modern endovascular and/or open revascularization according to the recommendations in the TASC II document.
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.
Active Comparator: NON-INVASIVE (NON) group
Patients receiving only best medical treatment (BMT).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months with intermistic analysis at 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Göteborg University

Investigators

  • Principal Investigator: Joakim Nordanstig, M D, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
  • Study Director: Lennart Jivegård, M D, PhD, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
  • Study Chair: Klas Österberg, M D, PhD, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
  • Study Chair: Johan Millinger, MD, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sahlgrenska Academy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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