Swedish Drug-elution Trial in Peripheral Arterial Disease
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- STATUS
- Recruiting
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- days left to enroll
- 28
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- participants needed
- 3800
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- sponsor
- Sahlgrenska University Hospital, Sweden
Summary
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.
Details
| 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 Identifier | NCT02051088 |
| Sponsor | Sahlgrenska University Hospital, Sweden |
| Last Modified on | 26 January 2021 |
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