Swedish Drug-elution Trial in Peripheral Arterial Disease

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.

Conditions

• Peripheral Arterial Disease
• Critical Limb Ischemia
• Intermittent Claudication

Interventions

PROCEDURE

Revascularization with drug-eluting technology

Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).

PROCEDURE

Revascularization without drug-eluting technology

Endovascular intervention without using drug-eluting balloons or stents

DEVICE

drug-coated balloons and/or drug-eluting stents

Sponsors & Collaborators

• The Swedish Research Council

  collaborator OTHER_GOV

• Swedish Heart Lung Foundation

  collaborator OTHER

• Uppsala University

  collaborator OTHER

• The Swedish National Registry for Vascular Surgery

  collaborator OTHER

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Mårten Falkenberg, MD, PhD · Department of Radiology, Sahlgrenska University Hospital

• Joakim Nordanstig, MD · Department of Vascular Surgery, Sahlgrenska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2025-04-30

Completion

2026-12-31

Countries

• Sweden

Study Locations