Swedish Drug-elution Trial in Peripheral Arterial Disease (SWEDEPAD)

Sahlgrenska University Hospital

Status: Active, not recruiting

Conditions: Intermittent Claudication; Critical Limb Ischemia; Peripheral Arterial Disease

Treatments: Procedure: Revascularization with drug-eluting technology; Device: drug-coated balloons and/or drug-eluting stents; Procedure: Revascularization without drug-eluting technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02051088

SWEDEPAD

Details and patient eligibility

About

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.

Enrollment: 3,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,800 participants in 2 patient groups

Revascularization with drug eluting technology

Experimental group

Description:

Revascularization with drug eluting technology

Treatment:

Procedure: Revascularization with drug-eluting technology

Device: drug-coated balloons and/or drug-eluting stents

Revascularization without drug elution

Active Comparator group

Description:

Revascularization without drug elution technology

Treatment:

Procedure: Revascularization without drug-eluting technology