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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sahlgrenska University Hospital, Sweden
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
ClinicalTrials.gov Identifier:
NCT02051088
First received: January 27, 2014
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Amputation rate (SWEDEPAD 1) [ Time Frame: Assessed when all patients have been followed for at least one year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Amputation-free survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ] [ Designated as safety issue: Yes ]
  • Survival [ Time Frame: Assessed when all participants have been followed for at least one, three and five years. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Patency [ Time Frame: Assessed after 1 month and 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Health-economic assessment [ Time Frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years ] [ Designated as safety issue: No ]
    Assessment of cost-effectiveness and clinical utility (only certain centres).


Estimated Enrollment: 3800
Study Start Date: November 2014
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Procedure: Revascularization without drug-eluting technology
Endovascular intervention without using drug-eluting balloons or stents

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02051088

Contacts
Contact: Mårten Falkenberg, MD, PhD +46 736 601629 marten.falkenberg@vgregion.se
Contact: Joakim Nordanstig, MD +46 708 259496 joakim.nordanstig@vgregion.se

Locations
Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden, 41345
Contact: Joakim Nordanstig, MD, Ph D    +46708259496    joakim.nordanstig@vgregion.se   
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
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

No publications provided

Responsible Party: Mårten Falkenberg, MD, PhD, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02051088     History of Changes
Other Study ID Numbers: SWEDEPAD
Study First Received: January 27, 2014
Last Updated: November 17, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Critical limb ischemia
Intermittent claudication
endovascular treatment
drug-elution

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014