Swedish External Support Study

Critical Limb Ischemia Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01273740
• Other study ID #: SWEXSUS
• Status: Completed
• Phase: N/A
• First received: January 7, 2011
• Last updated: January 7, 2011
• Start date: January 1995
• Est. completion date: June 1998

Study information

• Verified date: January 2011
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: June 1998
• Est. primary completion date: June 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia

Intervention

Procedure:
• External support
Bypass surgery with externally supported graft

Locations

Country	Name	City	State
n/a

Sponsors (29)

Lead Sponsor

Collaborator

University Hospital, Linkoeping

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary graft patency			No
Secondary	limb salvage			No