Invasive Revascularization or Not in Intermittent Claudication (IRONIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Joakim Nordanstig, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01219842
First received: October 12, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Intermittent Claudication
Procedure: INVASIVE (INV) treatment
Other: Best medical treatment (BMT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Invasive Revascularization or Not in Intermittent Claudication

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Health Related Quality of Life (HRQOL) [ Time Frame: 24 months with intermistic analysis at 12 months ] [ Designated as safety issue: No ]
    Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL


Secondary Outcome Measures:
  • Walking performance on treadmill test [ Time Frame: 24 months with interimistic analysis at 12 months ] [ Designated as safety issue: No ]
    Graded treadmill test with progressively increasing speed and inclination.


Estimated Enrollment: 162
Study Start Date: March 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219842

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
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 Gelin, MD PhD Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
  More Information

No publications provided

Responsible Party: Joakim Nordanstig, vascular surgeon, PhD student, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01219842     History of Changes
Other Study ID Numbers: Sahlgrenska Academy
Study First Received: October 12, 2010
Last Updated: March 3, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Intermittent claudication
Health Related Quality of Life
Walking performance
Daily walking capacity

Additional relevant MeSH terms:
Intermittent Claudication
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014