Swedish Drug-elution Trial in Peripheral Arterial Disease (SWEDEPAD)
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|ClinicalTrials.gov Identifier: NCT02051088|
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : May 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication||Procedure: Revascularization with drug-eluting technology Procedure: Revascularization without drug-eluting technology Device: drug-coated balloons and/or drug-eluting stents||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3800 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform|
|Study Start Date :||November 2014|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2021|
Experimental: Revascularization with drug eluting technology
Revascularization with drug eluting technology
Procedure: Revascularization with drug-eluting technology
Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
Device: drug-coated balloons and/or drug-eluting stents
Active Comparator: Revascularization without drug elution
Revascularization without drug elution technology
Procedure: Revascularization without drug-eluting technology
Endovascular intervention without using drug-eluting balloons or stents
- Amputation rate (SWEDEPAD 1) [ Time Frame: Assessed when all patients have been followed for at least one year ]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.
- Health-related quality of life (SWEDEPAD 2) [ Time Frame: Assessed one year after randomization ]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.
- Amputation-free survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
- Survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
- Target lesion revascularization (TLR) [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years. ]Need for re-intervention during follow-up
- Time to target lesion revascularization [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years. ]
- Patency [ Time Frame: Assessed after 1 month and 1 year ]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).
- Improvement in clinical symptoms, assessed with the Rutherford classification [ Time Frame: Assessed after one month and one year ]
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)
- Health-related quality of life (SWEDEPAD 1) [ Time Frame: Assessed after one year following randomisation ]Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6
- Amputation rate (SWEDEPAD 2) [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years ]
- Health-economic assessment [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years ]Assessment of cost-effectiveness and clinical utility (only certain centres).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051088
|Contact: Mårten Falkenberg, MD, PhD||+46 736 email@example.com|
|Contact: Joakim Nordanstig, MD||+46 708 firstname.lastname@example.org|
|Sahlgrenska University Hospital||Recruiting|
|Göteborg, Sweden, 41345|
|Contact: Joakim Nordanstig, MD, Ph D +46708259496 email@example.com|
|Principal Investigator:||Mårten Falkenberg, MD, PhD||Department of Radiology, Sahlgrenska University Hospital|
|Study Chair:||Joakim Nordanstig, MD||Department of Vascular Surgery, Sahlgrenska University Hospital|