Swedish External Support Study (SWEXSUS)

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: External support

• Study Type: Interventional
• Enrollment (Actual): 334
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External support; Bypass graft with external support	Procedure: External support; Bypass surgery with externally supported graft
Experimental: No external support; Bypass with graft without external support	Procedure: External support; Bypass surgery with externally supported graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
primary graft patency

Secondary Outcome Measures

Outcome Measure
limb salvage

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Karlstad Central Hospital; Lund University Hospital; Uppsala University Hospital; Malmö University; Helsingborgs Hospital; Region Västmanland; Borås Lasarett; Kalmar County Hospital; Västervik Hospital; Kristiansund Hospital; Falu Lasarett Röntgen; Eskilstuna Lasarettet; Lasarett Gävle; Lasarettet Boden; Department of Surgery, Sahlgrenska sjukhuset, Göteborg; Department of Surgery, Östra sjukhuset, Göteborg; 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; Department of Surgery, Lasarettet, Växjö; Department of Surgery, Lasarettet, Örebro; Department of Surgery, Lasarettet, Östersund
• Investigators: Principal Investigator: Fredrik BG Lundgren, PhD, MD, Department of CardioVascular Surgery, University Hospital, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 1995
• Primary Completion (Actual): June 1, 1998
• Study Completion (Actual): June 1, 1998

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 7, 2011
• First Posted (Estimate): January 10, 2011

Study Record Updates

• Last Update Posted (Estimate): January 10, 2011
• Last Update Submitted That Met QC Criteria: January 7, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: external support; PTFE bypass; femoro-popliteal; femoro-crural; popliteal arteries; crural arteries; crtical limb ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: SWEXSUS