ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02051088
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : May 16, 2017
Sponsor:
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

January 27, 2014
January 31, 2014
May 16, 2017
November 2014
June 2019   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02051088 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Swedish Drug-elution Trial in Peripheral Arterial Disease
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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Peripheral Arterial Disease
  • Critical Limb Ischemia
  • Intermittent Claudication
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3800
Same as current
June 2021
June 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Mårten Falkenberg, MD, PhD +46 736 601629 marten.falkenberg@vgregion.se
Contact: Joakim Nordanstig, MD +46 708 259496 joakim.nordanstig@vgregion.se
Sweden
 
 
NCT02051088
SWEDEPAD
Yes
Not Provided
Not Provided
Mårten Falkenberg, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
  • The Swedish Research Council
  • Swedish Heart Lung Foundation
  • Uppsala University
  • The Swedish National Registry for Vascular Surgery
Principal Investigator: Mårten Falkenberg, MD, PhD Department of Radiology, Sahlgrenska University Hospital
Study Chair: Joakim Nordanstig, MD Department of Vascular Surgery, Sahlgrenska University Hospital
Sahlgrenska University Hospital, Sweden
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP