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

• ClinicalTrials.gov Identifier: NCT02051088
• Recruitment Status: Active, not recruiting
• First Posted: January 31, 2014
• Last Update Posted: December 19, 2023
• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: The Swedish Research Council; Swedish Heart Lung Foundation; Uppsala University; The Swedish National Registry for Vascular Surgery
• Information provided by (Responsible Party): Mårten Falkenberg, Sahlgrenska University Hospital, Sweden

Tracking Information

• First Submitted Date: January 27, 2014
• First Posted Date: January 31, 2014
• Last Update Posted Date: December 19, 2023
• Actual Study Start Date: November 2014
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2014)

• Amputation rate (SWEDEPAD 1) [ Time Frame: Assessed when all patients have been followed for at least one year ]
  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.
• Health-related quality of life (SWEDEPAD 2) [ Time Frame: Assessed one year after randomization ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 30, 2014)

• Amputation-free survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
• Survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
• Target lesion revascularization (TLR) [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years. ]
  Need for re-intervention during follow-up
• Time to target lesion revascularization [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years. ]
• Patency [ Time Frame: Assessed after 1 month and 1 year ]
  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).
• Improvement in clinical symptoms, assessed with the Rutherford classification [ Time Frame: Assessed after one month and one year ]
  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)
• Health-related quality of life (SWEDEPAD 1) [ Time Frame: Assessed after one year following randomisation ]
  Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6
• Amputation rate (SWEDEPAD 2) [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years ]
• Health-economic assessment [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years ]
  Assessment of cost-effectiveness and clinical utility (only certain centres).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Peripheral Arterial Disease
• Critical Limb Ischemia
• Intermittent Claudication

Intervention

• 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

Study Arms

• Experimental: Revascularization with drug eluting technology
  Revascularization with drug eluting technology
  Interventions:

  • Procedure: Revascularization with drug-eluting technology
  • Device: drug-coated balloons and/or drug-eluting stents
• Active Comparator: Revascularization without drug elution
  Revascularization without drug elution technology
  Intervention: Procedure: Revascularization without drug-eluting technology

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 30, 2014): 3800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT02051088
• Other Study ID Numbers: SWEDEPAD
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mårten Falkenberg, Sahlgrenska University Hospital, Sweden
• Original Responsible Party: Same as current
• Current Study Sponsor: Sahlgrenska University Hospital, Sweden
• Original Study Sponsor: Same as current

Collaborators

• The Swedish Research Council
• Swedish Heart Lung Foundation
• Uppsala University
• 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

• PRS Account: Sahlgrenska University Hospital, Sweden
• Verification Date: April 2023