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

Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Disease; Intermittent Claudication; Critical Limb Ischemia
• Intervention / Treatment: Procedure: Revascularization with drug-eluting technology; Device: drug-coated balloons and/or drug-eluting stents; Procedure: Revascularization without drug-eluting technology

• Study Type: Interventional
• Enrollment (Actual): 3556
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revascularization with drug eluting technology	Procedure: Revascularization with drug-eluting technology; Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).; Device: drug-coated balloons and/or drug-eluting stents
Active Comparator: Revascularization without drug elution; Revascularization without drug elution technology	Procedure: Revascularization without drug-eluting technology; Endovascular intervention without using drug-eluting balloons or stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation rate (SWEDEPAD 1)	Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year.	Assessed when all patients have been followed for at least one year
Health-related quality of life (SWEDEPAD 2)	Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD.	Assessed one year after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation-free survival		Assessed when all participants have been followed for at least one, three and five years.
Survival		Assessed when all participants have been followed for at least one, three and five years.
Target lesion revascularization (TLR)	Need for re-intervention during follow-up	Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Time to target lesion revascularization		Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Patency	Patency, defined as freedom from binary restenosis, a reduction in lumen diameter ≥50% in patients assessed with duplex ultrasound after one month and after one year (only certain centres).	Assessed after 1 month and 1 year
Improvement in clinical symptoms, assessed with the Rutherford classification	Particularly changes from Rutherford categories 4, 5 and 6 to lower categories will analysed (SWEDEPAD 1) Particularly changes from Rutherford categories 2 and 3 to other categories will analysed (SWEDEPAD 2)	Assessed after one month and one year
Health-related quality of life (SWEDEPAD 1)	Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6	Assessed after one year following randomisation
Amputation rate (SWEDEPAD 2)		Assessed one year after the intervention and when all participants have been followed for one, three and five years
Health-economic assessment	Assessment of cost-effectiveness and clinical utility (only certain centres).	Assessed one year after the intervention and when all participants have been followed for one, three and five years

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Collaborators: Uppsala University; The Swedish Research Council; Swedish Heart Lung Foundation; The Swedish National Registry for Vascular Surgery
• Investigators: Principal Investigator: Mårten Falkenberg, MD, PhD, Department of Radiology, Sahlgrenska University Hospital; Study Chair: Joakim Nordanstig, MD, Department of Vascular Surgery, Sahlgrenska University Hospital

Publications and helpful links

General Publications

• Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engstrom J, Fransson T, Hamoud M, Hilbertson A, Johansson P, Karlsson L, Kragsterman B, Lindgren H, Ludwigs K, Mellander S, Nyman N, Renlund H, Sigvant B, Skoog P, Starck J, Tegler G, Toivola A, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 27, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimated): January 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: endovascular treatment; Critical limb ischemia; Intermittent claudication; drug-elution
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Limb-Threatening Ischemia; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: SWEDEPAD