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| Name | Class |
|---|---|
| The Swedish Research Council | OTHER_GOV |
| Swedish Heart Lung Foundation | OTHER |
| Uppsala University | OTHER |
| The Swedish National Registry for Vascular Surgery |
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Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).
In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.
In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revascularization with drug eluting technology | Experimental | Revascularization with drug eluting technology |
|
| Revascularization without drug elution | Active Comparator | Revascularization without drug elution technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revascularization with drug-eluting technology | Procedure | Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amputation rate (SWEDEPAD 1) | Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year. | Assessed when all patients have been followed for at least one year |
| Health-related quality of life (SWEDEPAD 2) | Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD. | Assessed one year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free survival | Assessed when all participants have been followed for at least one, three and five years. | |
| Survival | Assessed when all participants have been followed for at least one, three and five years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mårten Falkenberg, MD, PhD | Department of Radiology, Sahlgrenska University Hospital | Principal Investigator |
| Joakim Nordanstig, MD | Department of Vascular Surgery, Sahlgrenska University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40902617 | Derived | Falkenberg M, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1103-1114. doi: 10.1016/S0140-6736(25)01585-5. Epub 2025 Aug 31. | |
| 40902614 |
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| OTHER |
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| Revascularization without drug-eluting technology | Procedure | Endovascular intervention without using drug-eluting balloons or stents |
|
| drug-coated balloons and/or drug-eluting stents | Device |
|
| Target lesion revascularization (TLR) | Need for re-intervention during follow-up | Assessed one year after the intervention and when all participants have been followed for one, three and five years. |
| Time to target lesion revascularization | Assessed one year after the intervention and when all participants have been followed for one, three and five years. |
| Patency | Patency, defined as freedom from binary restenosis, a reduction in lumen diameter ≥50% in patients assessed with duplex ultrasound after one month and after one year (only certain centres). | Assessed after 1 month and 1 year |
| Improvement in clinical symptoms, assessed with the Rutherford classification | Particularly changes from Rutherford categories 4, 5 and 6 to lower categories will analysed (SWEDEPAD 1) Particularly changes from Rutherford categories 2 and 3 to other categories will analysed (SWEDEPAD 2) | Assessed after one month and one year |
| Health-related quality of life (SWEDEPAD 1) | Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6 | Assessed after one year following randomisation |
| Amputation rate (SWEDEPAD 2) | Assessed one year after the intervention and when all participants have been followed for one, three and five years |
| Health-economic assessment | Assessment of cost-effectiveness and clinical utility (only certain centres). | Assessed one year after the intervention and when all participants have been followed for one, three and five years |
| Derived |
| Nordanstig J, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1115-1127. doi: 10.1016/S0140-6736(25)01584-3. Epub 2025 Aug 31. |
| 33296560 | Derived | Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engstrom J, Fransson T, Hamoud M, Hilbertson A, Johansson P, Karlsson L, Kragsterman B, Lindgren H, Ludwigs K, Mellander S, Nyman N, Renlund H, Sigvant B, Skoog P, Starck J, Tegler G, Toivola A, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9. |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D000089802 | Chronic Limb-Threatening Ischemia |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D012816 | Signs and Symptoms |
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