Invasive Revascularization or Not in Intermittent Claudication

NCT ID: NCT01219842

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2020-06-30

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.

Conditions

Intermittent Claudication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INVASIVE (INV) group

Modern endovascular and/or open revascularization according to the recommendations in the TASC II document.

Group Type: ACTIVE_COMPARATOR

INVASIVE (INV) treatment

Intervention Type: PROCEDURE

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

Best medical treatment (BMT)

Intervention Type: OTHER

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

NON-INVASIVE (NON) group

Patients receiving only best medical treatment (BMT).

Group Type: ACTIVE_COMPARATOR

Best medical treatment (BMT)

Intervention Type: OTHER

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

Interventions

INVASIVE (INV) treatment

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

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joakim Nordanstig

vascular surgeon, PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joakim Nordanstig, M D

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

Lennart Jivegård, M D, PhD

Role: STUDY_DIRECTOR

Sahlgrenska Academy, Institute of Medicine, department of Molecular and Clinical Medicine

Klas Österberg, M D, PhD

Role: STUDY_CHAIR

Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

Johan Millinger, MD

Role: STUDY_CHAIR

Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

References

Djerf H, Millinger J, Falkenberg M, Jivegard L, Svensson M, Nordanstig J. Absence of Long-Term Benefit of Revascularization in Patients With Intermittent Claudication: Five-Year Results From the IRONIC Randomized Controlled Trial. Circ Cardiovasc Interv. 2020 Jan;13(1):e008450. doi: 10.1161/CIRCINTERVENTIONS.119.008450. Epub 2020 Jan 15.

Reference Type: DERIVED

PMID: 31937137 (View on PubMed)

Nordanstig J, Taft C, Hensater M, Perlander A, Osterberg K, Jivegard L. Two-year results from a randomized clinical trial of revascularization in patients with intermittent claudication. Br J Surg. 2016 Sep;103(10):1290-9. doi: 10.1002/bjs.10198. Epub 2016 May 25.

Reference Type: DERIVED

PMID: 27220310 (View on PubMed)

Nordanstig J, Taft C, Hensater M, Perlander A, Osterberg K, Jivegard L. Improved quality of life after 1 year with an invasive versus a noninvasive treatment strategy in claudicants: one-year results of the Invasive Revascularization or Not in Intermittent Claudication (IRONIC) Trial. Circulation. 2014 Sep 16;130(12):939-47. doi: 10.1161/CIRCULATIONAHA.114.009867. Epub 2014 Aug 5.

Reference Type: DERIVED

PMID: 25095886 (View on PubMed)

Other Identifiers

Sahlgrenska Academy

Identifier Type: -

Identifier Source: org_study_id