Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Göteborg University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INVASIVE (INV) group | Active Comparator | Modern endovascular and/or open revascularization according to the recommendations in the TASC II document. |
|
| NON-INVASIVE (NON) group | Active Comparator | Patients receiving only best medical treatment (BMT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INVASIVE (INV) treatment | Procedure | Modern endovascular and/or open revascularisation according to the TASC II recommendations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Walking performance on treadmill test | Graded treadmill test with progressively increasing speed and inclination. | 24 months with interimistic analysis at 12 months |
| Health Related Quality of Life (HRQOL) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31937137 | Derived | 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. | |
| 27220310 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Assessed with the patient-reported instruments SF-36, EQ5D and VASCUQOL
| 60 months |
| Walking performance on treadmill test | Graded treadmill test with progressively increasing speed and inclination. | 60 months |
| six-minutes walk test | Corridor-based walk test during six minutes walk | 60 months |
| 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. |
| 25095886 | Derived | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |