Scandinavian Miller Collar Study (SCAMICOS)

University Hospital, Linkoeping

Status: Completed

Conditions: Critical Limb Ischemia

Treatments: Procedure: Vein collar at the distal anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01285986

SCAMICOS

Details and patient eligibility

About

Randomized study to evaluate the effect of adding a vein collar at the distal anastomosis 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: 352 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Critical limb ischemia
• Need for bypass surgery

Exclusion criteria

• Can not 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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352 participants in 2 patient groups

Vein collar at distal anastomosis

Experimental group

Description:

Vein collar at the distal anastomosis

Treatment:

Procedure: Vein collar at the distal anastomosis

No vein collar at the distal anastomosis

Experimental group

Description:

No vein collar at the distal anastomosis

Treatment:

Procedure: Vein collar at the distal anastomosis