Swedish Drug-elution Trial in Peripheral Arterial Disease

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    Sahlgrenska University Hospital, Sweden
Updated on 26 January 2021
coronary artery disease
endovascular intervention
vascular disease
limb ischemia
rest pain
intermittent claudication
critical limb ischaemia
ischemic ulcer
transluminal angioplasty
endovascular procedure


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 Peripheral vascular disease, Circulation Disorders, Peripheral vascular disease, peripheral arterial disease, Peripheral Arterial Disease (PAD), Intermittent Claudication, Claudication, Intermittent Claudication, Circulation Disorders, Critical Limb Ischemia, Claudication, Critical Limb Ischaemia, Peripheral Arterial Disease (PAD), peripheral arterial diseases, peripheral artery disease
Treatment Revascularization with drug-eluting technology, Revascularization without drug-eluting technology, drug-coated balloons and/or drug-eluting stents
Clinical Study IdentifierNCT02051088
SponsorSahlgrenska University Hospital, Sweden
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

All adults > 18 years old willing to be randomized
Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications

Exclusion Criteria

Acute thromboembolic disease in the leg
Infrainguinal aneurysmal disease
Previous participation in the study or in other randomised interventional study of infrainguinal lesions
Patients without a Swedish personal identification number
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