Clinical trial NCT01219842: Invasive Revascularization or Not in Intermittent Claudication
Official title: Invasive Revascularization or Not in Intermittent Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Claudication
Keywords: Intermittent claudication
Health Related Quality of Life
Walking performance
Daily walking capacity
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2010-10-13
Enrollment: 159
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: 24 months with intermistic analysis at 12 months
Secondary outcomes:
measure: Walking performance on treadmill test
timeFrame: 24 months with interimistic analysis at 12 months
measure: Health Related Quality of Life (HRQOL)
timeFrame: 60 months
measure: Walking performance on treadmill test
timeFrame: 60 months
measure: six-minutes walk test
timeFrame: 60 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
name: Joakim Nordanstig, M D
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska Academy, Institute of Medicine, department of Molecular and Clinical Medicine
name: Lennart Jivegård, M D, PhD
role: STUDY_DIRECTOR
affiliation: Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
name: Klas Österberg, M D, PhD
role: STUDY_CHAIR
affiliation: Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
name: Johan Millinger, MD
role: STUDY_CHAIR
References:
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.
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.
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.