Swedish External Support Study

Not Applicable

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: External support

• Registration Number: NCT01273740
• Lead Sponsor: University Hospital, Linkoeping

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 available

Study Timeline

• Study Start: 1995-01
• Primary Completion: 1998-06
• Study Completion: 1998-06
• Status Verified: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Last Update Submitted: 2011-01-07
• Study First Posted: 2011-01-10
• Last Update Posted: 2011-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 334

Inclusion Criteria

Critical limb ischemia Need for bypass surgery

Exclusion Criteria

Can participate in follow-up Has suitable saphenous vein

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External support	External support	Bypass graft with external support
No external support	External support	Bypass with graft without external support

Primary Outcome Measures

Name	Time	Method
primary graft patency

Secondary Outcome Measures

Name	Time	Method
limb salvage