NCT01219842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

October 12, 2010

Last Update Submit

March 17, 2021

Conditions

Intermittent Claudication

Keywords

Intermittent claudicationHealth Related Quality of LifeWalking performanceDaily walking capacity

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life (HRQOL)

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

    24 months with intermistic analysis at 12 months

Secondary Outcomes (4)

  • Walking performance on treadmill test

    24 months with interimistic analysis at 12 months

  • Health Related Quality of Life (HRQOL)

    60 months

  • Walking performance on treadmill test

    60 months

  • six-minutes walk test

    60 months

Study Arms (2)

INVASIVE (INV) group

ACTIVE COMPARATOR

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

Procedure: INVASIVE (INV) treatmentOther: Best medical treatment (BMT)

NON-INVASIVE (NON) group

ACTIVE COMPARATOR

Patients receiving only best medical treatment (BMT).

Other: Best medical treatment (BMT)

Interventions

INVASIVE (INV) treatmentPROCEDURE

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

INVASIVE (INV) group
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.

INVASIVE (INV) groupNON-INVASIVE (NON) group

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with intermittent claudication (typical symptoms and ABI \<0.9) seeking treatment
  • Significant aortoiliac- and/or femoropopliteal lesion.
  • Age 30-80 years

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 31937137DERIVED

  • 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.

    PMID: 27220310DERIVED

  • 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.

    PMID: 25095886DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joakim Nordanstig, M D

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

    PRINCIPAL INVESTIGATOR

  • Lennart Jivegård, M D, PhD

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

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vascular surgeon, PhD student

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2014

Study Completion

June 1, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations

SE(1)