Swedish Drug-elution Trial in Peripheral Arterial Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Revascularization with drug eluting technology

Group Type EXPERIMENTAL

Revascularization with drug-eluting technology

Intervention Type PROCEDURE

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

drug-coated balloons and/or drug-eluting stents

Intervention Type DEVICE

Revascularization without drug elution

Revascularization without drug elution technology

Group Type ACTIVE_COMPARATOR

Revascularization without drug-eluting technology

Intervention Type PROCEDURE

Endovascular intervention without using drug-eluting balloons or stents

Interventions

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Revascularization with drug-eluting technology

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

Intervention Type PROCEDURE

Revascularization without drug-eluting technology

Endovascular intervention without using drug-eluting balloons or stents

Intervention Type PROCEDURE

drug-coated balloons and/or drug-eluting stents

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No