Intermittent ClaudicationIRONICNCT01219842
Invasive Revascularization or Not in Intermittent Claudication
A study testing INVASIVE (INV) treatment and Best medical treatment (BMT) in people with Intermittent Claudication, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- INVASIVE (INV) treatment and Best medical treatment (BMT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2010to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with intermittent claudication (typical symptoms and ABI <0.9) seeking treatment
- Significant aortoiliac- and/or femoropopliteal lesion.
- Age 30-80 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- INVASIVE (INV) treatment, Best medical treatment (BMT)
- Keywords
- Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVASIVE (INV) treatmentProcedure or surgery
Modern endovascular and/or open revascularisation according to the TASC II recommendations.
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.
| Study group | Role | What they receive |
|---|---|---|
| INVASIVE (INV) group | Active comparator | Modern endovascular and/or open revascularization according to the recommendations in the TASC II document. Receives: Procedure: INVASIVE (INV) treatment; Other: Best medical treatment (BMT) |
| NON-INVASIVE (NON) group | Active comparator | Patients receiving only best medical treatment (BMT). Receives: Other: Best medical treatment (BMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQOL)
Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
Measured: 24 months with intermistic analysis at 12 months
Secondary outcomes (4)
Walking performance on treadmill test
Graded treadmill test with progressively increasing speed and inclination.
Measured: 24 months with interimistic analysis at 12 months
Health Related Quality of Life (HRQOL)
Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
Measured: 60 months
Walking performance on treadmill test
Graded treadmill test with progressively increasing speed and inclination.
Measured: 60 months
six-minutes walk test
Corridor-based walk test during six minutes walk
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Joakim Nordanstig, Sahlgrenska University Hospital
- Investigators
- Joakim Nordanstig, M D, Principal investigator, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical MedicineLennart Jivegård, M D, PhD, Study director, Sahlgrenska Academy, Institute of Medicine, department of Molecular and Clinical MedicineKlas Österberg, M D, PhD, Study chair, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical MedicineJohan Millinger, MD, Study chair, Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219842
- Sponsor's protocol ID
- Sahlgrenska Academy
- Acronym
- IRONIC
- Status last verified
- Mar 2021
- First submitted
- 12 Oct 2010
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31937137Nordanstig 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.
PubMed 27220310Nordanstig 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.
PubMed 25095886
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Revascularization or Not in Intermittent Claudication
- ClinicalTrials.gov ID
- NCT01219842
- Acronym / sponsor ID
- IRONIC / Sahlgrenska Academy
- Conditions
- Intermittent Claudication
- Keywords
- Intermittent claudication, Health Related Quality of Life, Walking performance, Daily walking capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INVASIVE (INV) group | Active comparator | Procedure: INVASIVE (INV) treatment, Other: Best medical treatment (BMT)Modern endovascular and/or open revascularization according to the recommendations in the TASC II document. |
| NON-INVASIVE (NON) group | Active comparator | Other: Best medical treatment (BMT)Patients receiving only best medical treatment (BMT). |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with intermittent claudication (typical symptoms and ABI <0.9) seeking treatment
- Significant aortoiliac- and/or femoropopliteal lesion.
- Age 30-80 years
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INVASIVE (INV) treatmentModern endovascular and/or open revascularisation according to the TASC II recommendations. | Procedure or surgery | INVASIVE (INV) group |
| 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. | Other | INVASIVE (INV) group, NON-INVASIVE (NON) group |
Primary outcome
Health Related Quality of Life (HRQOL)
Time frame: 24 months with intermistic analysis at 12 months
Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
4 secondary outcomes
Walking performance on treadmill test
Time frame: 24 months with interimistic analysis at 12 months
Health Related Quality of Life (HRQOL)
Time frame: 60 months
Walking performance on treadmill test
Time frame: 60 months
six-minutes walk test
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 31937137Djerf 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.
- Derived from this study: PubMed 27220310Nordanstig 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.
- Derived from this study: PubMed 25095886Nordanstig 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joakim Nordanstig, M D principal investigator
Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
Lennart Jivegård, M D, PhD study director
Sahlgrenska Academy, Institute of Medicine, department of Molecular and Clinical Medicine
Klas Österberg, M D, PhD study chair
Sahlgrenska Academy, Institute of Medicine, Department of Molecular and Clinical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INVASIVE (INV) treatment and Best medical treatment (BMT) in people with Intermittent Claudication, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQOL) (time frame: 24 months with intermistic analysis at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219842, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.