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Swedish External Support Study (SWEXSUS)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01273740
Recruitment Status : Completed
First Posted : January 10, 2011
Last Update Posted : January 10, 2011
Sponsor:
Collaborators:
Information provided by:

January 7, 2011
January 10, 2011
January 10, 2011
January 1995
June 1998   (Final data collection date for primary outcome measure)
primary graft patency
Same as current
No Changes Posted
limb salvage
Same as current
Not Provided
Not Provided
 
Swedish External Support Study
Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Critical Limb Ischemia
Procedure: External support
Bypass surgery with externally supported graft
  • Experimental: External support
    Bypass graft with external support
    Intervention: Procedure: External support
  • Experimental: No external support
    Bypass with graft without external support
    Intervention: Procedure: External support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
June 1998
June 1998   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01273740
SWEXSUS
No
Not Provided
Not Provided
Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden
University Hospital, Linkoeping
  • 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
Principal Investigator: Fredrik BG Lundgren, PhD, MD Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
University Hospital, Linkoeping
January 2011

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