Swedish External Support Study (SWEXSUS)

University Hospital, Linkoeping

Status: Completed

Conditions: Critical Limb Ischemia

Treatments: Procedure: External support

Study type: Interventional

Funder types: Other

Identifiers

NCT01273740

SWEXSUS

Details and patient eligibility

About

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.

Enrollment: 334 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Critical limb ischemia Need for bypass surgery

Exclusion criteria

Can participate in follow-up Has suitable saphenous vein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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334 participants in 2 patient groups

External support

Experimental group

Description:

Bypass graft with external support

Treatment:

Procedure: External support

No external support

Experimental group

Description:

Bypass with graft without external support

Treatment:

Procedure: External support