Scandinavian Miller Collar Study

Not Applicable

Completed

• Conditions: Critical Limb Ischemia
• Interventions: Procedure: Vein collar at the distal anastomosis

• Registration Number: NCT01285986
• Lead Sponsor: University Hospital, Linkoeping

Brief Summary

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

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: 2011-01-27
• Study First Submitted QC: 2011-01-27
• Last Update Submitted: 2011-01-27
• Study First Posted: 2011-01-28
• Last Update Posted: 2011-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Critical limb ischemia
• Need for bypass surgery

Exclusion Criteria

• Can not participate in follow-up
• Has suitable saphenous vein

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vein collar at distal anastomosis	Vein collar at the distal anastomosis	Vein collar at the distal anastomosis
No vein collar at the distal anastomosis	Vein collar at the distal anastomosis	No vein collar at the distal anastomosis

Primary Outcome Measures

Name	Time	Method
Primary graft patency	Up to five years	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.

Secondary Outcome Measures

Name	Time	Method
Secondary Patency	Up to five years	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.

Trial Locations

Locations (1)

Department of CardioVascular Surgery, University Hospital; 🇸🇪 Linköping, Sweden