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Swedish External Support Study (SWEXSUS)

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
External support
Sponsored by
University Hospital, Linkoeping
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring PTFE bypass, femoro-popliteal, femoro-crural, popliteal arteries, crural arteries, external support, crtical limb ischemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    External support

    No external support

    Arm Description

    Bypass graft with external support

    Bypass with graft without external support

    Outcomes

    Primary Outcome Measures

    primary graft patency

    Secondary Outcome Measures

    limb salvage

    Full Information

    First Posted
    January 7, 2011
    Last Updated
    January 7, 2011
    Sponsor
    University Hospital, Linkoeping
    Collaborators
    Lasarettet Boden, Borås Lasarett, Eskilstuna Lasarettet, Falu Lasarett Röntgen, Department of Surgery, Sahlgrenska sjukhuset, Göteborg, Department of Surgery, Östra sjukhuset, Göteborg, Lasarett Gävle, Helsingborgs Hospital, Kalmar County Hospital, Karlstad Central Hospital, Kristiansund Hospital, Lund University Hospital, Malmö University, Department of Surgery, Lasarettet, Motala, Department of Surgery, Lasarettet, Mölndal, Department of Surgery, Lasarettet, Norrköping, Department of Surgery, Lasarettet, Nyköping, Department of Surgery, Lasarettet, Skellefteå, Department of Surgery, Kärnsjukhuset, Skövde, Department of Surgery, S:t Görans Sjukhus, Stockholm, Department of Surgery, Södersjukhuset, Stockholm, Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Uppsala University Hospital, Västervik Hospital, Region Västmanland, Department of Surgery, Lasarettet, Växjö, Department of Surgery, Lasarettet, Örebro, Department of Surgery, Lasarettet, Östersund
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01273740
    Brief Title
    Swedish External Support Study
    Acronym
    SWEXSUS
    Official Title
    Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1995 (undefined)
    Primary Completion Date
    June 1998 (Actual)
    Study Completion Date
    June 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital, Linkoeping
    Collaborators
    Lasarettet Boden, Borås Lasarett, Eskilstuna Lasarettet, Falu Lasarett Röntgen, Department of Surgery, Sahlgrenska sjukhuset, Göteborg, Department of Surgery, Östra sjukhuset, Göteborg, Lasarett Gävle, Helsingborgs Hospital, Kalmar County Hospital, Karlstad Central Hospital, Kristiansund Hospital, Lund University Hospital, Malmö University, Department of Surgery, Lasarettet, Motala, Department of Surgery, Lasarettet, Mölndal, Department of Surgery, Lasarettet, Norrköping, Department of Surgery, Lasarettet, Nyköping, Department of Surgery, Lasarettet, Skellefteå, Department of Surgery, Kärnsjukhuset, Skövde, Department of Surgery, S:t Görans Sjukhus, Stockholm, Department of Surgery, Södersjukhuset, Stockholm, Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Uppsala University Hospital, Västervik Hospital, Region Västmanland, Department of Surgery, Lasarettet, Växjö, Department of Surgery, Lasarettet, Örebro, Department of Surgery, Lasarettet, Östersund

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Critical Limb Ischemia
    Keywords
    PTFE bypass, femoro-popliteal, femoro-crural, popliteal arteries, crural arteries, external support, crtical limb ischemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    334 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    External support
    Arm Type
    Experimental
    Arm Description
    Bypass graft with external support
    Arm Title
    No external support
    Arm Type
    Experimental
    Arm Description
    Bypass with graft without external support
    Intervention Type
    Procedure
    Intervention Name(s)
    External support
    Intervention Description
    Bypass surgery with externally supported graft
    Primary Outcome Measure Information:
    Title
    primary graft patency
    Secondary Outcome Measure Information:
    Title
    limb salvage

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Critical limb ischemia Need for bypass surgery Exclusion Criteria: Can participate in follow-up Has suitable saphenous vein
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fredrik BG Lundgren, PhD, MD
    Organizational Affiliation
    Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Swedish External Support Study

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