Scandinavian Miller Collar Study

University Hospital, Linkoeping352 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

352

Conditions

Critical Limb Ischemia

Interventions

Vein collar at the distal anastomosisPROCEDURE

Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Critical limb ischemia * Need for bypass surgery Exclusion Criteria: * Can not participate in follow-up * Has suitable saphenous vein

Locations (1)

Department of CardioVascular Surgery, University Hospital

Linköping, Sweden

Outcomes

Primary Outcomes

Primary graft patency

Follow-up at 1, 3, 6, and 12. Thereafter at most 5 years or until death of patient or amputation of limb. Primary graft patency = patent graft without any intervention to open up or prevent a graft ocklusion. Methods used for verification of patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.

Time frame: Up to five years

Secondary Outcomes

Secondary Patency

Secondary patency = patent graft after one or several interventions to open up or prevent a graft occlusion. Methods used for verification of secondary patency: angiography, duplex, an improved ankle-brachial index was mantained, palpable pulse, or bi- or triphasic Doppler signal over the graft.

Time frame: Up to five years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.