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

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ClinicalTrials.gov Identifier: NCT02051088
Recruitment Status : Active, not recruiting
First Posted : January 31, 2014
Last Update Posted : December 19, 2023
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication Procedure: Revascularization with drug-eluting technology Procedure: Revascularization without drug-eluting technology Device: drug-coated balloons and/or drug-eluting stents Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 2014
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Revascularization with drug eluting technology
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Amputation-free survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
  2. Survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ]
  3. 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

  4. 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. ]
  5. 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).

  6. 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)


  7. 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

  8. 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 ]
  9. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051088


Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Sweden, 41345
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
The Swedish Research Council
Swedish Heart Lung Foundation
Uppsala University
The Swedish National Registry for Vascular Surgery
Investigators
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Principal Investigator: Mårten Falkenberg, MD, PhD Department of Radiology, Sahlgrenska University Hospital
Study Chair: Joakim Nordanstig, MD Department of Vascular Surgery, Sahlgrenska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mårten Falkenberg, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02051088    
Other Study ID Numbers: SWEDEPAD
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: December 19, 2023
Last Verified: April 2023
Keywords provided by Mårten Falkenberg, Sahlgrenska University Hospital, Sweden:
Critical limb ischemia
Intermittent claudication
endovascular treatment
drug-elution
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Chronic Limb-Threatening Ischemia
Intermittent Claudication
Ischemia
Pathologic Processes
Atherosclerosis
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Chronic Disease
Disease Attributes