Swedish Drug-elution Trial in Peripheral Arterial Disease

NCT02051088 | Active Not Recruiting DMC

• 1 other identifier: SWEDEPAD
• Study Type: interventional
• Target: 3,556
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Critical limb ischemia; Intermittent claudication; endovascular treatment; drug-elution

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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)

  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

  Assessed after 1 month and 1 year

Study Arms (2)

Revascularization with drug eluting technology

EXPERIMENTAL

Revascularization with drug eluting technology

Procedure: Revascularization with drug-eluting technology; Device: drug-coated balloons and/or drug-eluting stents

Revascularization without drug elution

ACTIVE COMPARATOR

Revascularization without drug elution technology

Procedure: Revascularization without drug-eluting technology

Interventions

Revascularization with drug-eluting technology PROCEDURE

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

Revascularization with drug eluting technology

Revascularization without drug-eluting technology PROCEDURE

Endovascular intervention without using drug-eluting balloons or stents

Revascularization without drug elution

drug-coated balloons and/or drug-eluting stents DEVICE

Revascularization with drug eluting technology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• The Swedish Research Council: collaborator
• Swedish Heart Lung Foundation: collaborator
• Uppsala University: collaborator
• The Swedish National Registry for Vascular Surgery: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (3)

• Falkenberg M, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1103-1114. doi: 10.1016/S0140-6736(25)01585-5. Epub 2025 Aug 31.

  PMID: 40902617 DERIVED

• Nordanstig J, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1115-1127. doi: 10.1016/S0140-6736(25)01584-3. Epub 2025 Aug 31.

  PMID: 40902614 DERIVED

• 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.

  PMID: 33296560 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Signs and Symptoms

Study Officials

• Mårten Falkenberg, MD, PhD

  Department of Radiology, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Joakim Nordanstig, MD

  Department of Vascular Surgery, Sahlgrenska University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: November 1, 2014
• Primary Completion: April 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

SE (1)