Swedish External Support Study (SWEXSUS)

Tracking Information
First Submitted Date ICMJE	January 7, 2011
First Posted Date ICMJE	January 10, 2011
Last Update Posted Date	January 10, 2011
Study Start Date ICMJE	January 1995
Actual Primary Completion Date	June 1998 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 7, 2011)	primary graft patency
Original Primary Outcome Measures ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ICMJE; (submitted: January 7, 2011)	limb salvage
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Swedish External Support Study
Official Title ICMJE	Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Critical Limb Ischemia
Intervention ICMJE	Procedure: External support; Bypass surgery with externally supported graft
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 7, 2011)	334
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	June 1998
Actual Primary Completion Date	June 1998 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Critical limb ischemia Need for bypass surgery Exclusion Criteria: Can participate in follow-up Has suitable saphenous vein
Sex/Gender	Sexes Eligible for Study: All
Ages	20 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01273740
Other Study ID Numbers ICMJE	SWEXSUS
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden
Study Sponsor ICMJE	University Hospital, Linkoeping
Collaborators ICMJE	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
Investigators ICMJE	Principal Investigator: Fredrik BG Lundgren, PhD, MD Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
PRS Account	University Hospital, Linkoeping
Verification Date	January 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP