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Invasive Revascularization or Not in Intermittent Claudication (IRONIC)

Primary Purpose

Intermittent Claudication

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

INVASIVE (INV) treatment

Best medical treatment (BMT)

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

INVASIVE (INV) group

NON-INVASIVE (NON) group

Arm Description

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

Patients receiving only best medical treatment (BMT).

Outcomes

Primary Outcome Measures

Health Related Quality of Life (HRQOL)

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

Secondary Outcome Measures

Walking performance on treadmill test

Graded treadmill test with progressively increasing speed and inclination.

Health Related Quality of Life (HRQOL)

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

Walking performance on treadmill test

Graded treadmill test with progressively increasing speed and inclination.

six-minutes walk test

Corridor-based walk test during six minutes walk

Full Information

NCT ID

NCT01219842

First Posted

October 12, 2010

Last Updated

March 17, 2021

Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Göteborg University

1. Study Identification

Unique Protocol Identification Number

NCT01219842

Brief Title

Invasive Revascularization or Not in Intermittent Claudication

Acronym

IRONIC

Official Title

Invasive Revascularization or Not in Intermittent Claudication

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sahlgrenska University Hospital, Sweden

Collaborators

Göteborg University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intermittent Claudication

Keywords

Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

159 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INVASIVE (INV) group

Arm Type

Active Comparator

Arm Description

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

Arm Title

NON-INVASIVE (NON) group

Arm Type

Active Comparator

Arm Description

Patients receiving only best medical treatment (BMT).

Intervention Type

Procedure

Intervention Name(s)

INVASIVE (INV) treatment

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Best medical treatment (BMT)

Intervention Description

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

Primary Outcome Measure Information:

Title

Health Related Quality of Life (HRQOL)

Description

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

Time Frame

24 months with intermistic analysis at 12 months

Secondary Outcome Measure Information:

Title

Walking performance on treadmill test

Description

Graded treadmill test with progressively increasing speed and inclination.

Time Frame

24 months with interimistic analysis at 12 months

Title

Health Related Quality of Life (HRQOL)

Description

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

Time Frame

60 months

Title

Walking performance on treadmill test

Description

Graded treadmill test with progressively increasing speed and inclination.

Time Frame

60 months

Title

six-minutes walk test

Description

Corridor-based walk test during six minutes walk

Time Frame

60 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joakim Nordanstig, M D

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lennart Jivegård, M D, PhD

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Klas Österberg, M D, PhD

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Johan Millinger, MD

Organizational Affiliation

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

Official's Role

Study Chair

Facility Information:

Facility Name

Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

31937137

Citation

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.

Results Reference

derived

PubMed Identifier

27220310

Citation

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.

Results Reference

derived

PubMed Identifier

25095886

Citation

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.

Results Reference

derived

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Invasive Revascularization or Not in Intermittent Claudication

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