Scandinavian Miller Collar Study (SCAMICOS)

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 Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Procedure: Vein collar at the distal anastomosis

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Linköping, Sweden, 581 85
    • Department of CardioVascular Surgery, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Critical limb ischemia
• Need for bypass surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vein collar at distal anastomosis; Vein collar at the distal anastomosis	Procedure: Vein collar at the distal anastomosis; Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
Experimental: No vein collar at the distal anastomosis	Procedure: Vein collar at the distal anastomosis; Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to five years

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; Aalborg University Hospital; Karlstad Central Hospital; Lund University Hospital; Uppsala University Hospital; Malmö University; Helsingborgs Hospital; Region Västmanland; Borås Lasarett; Kalmar County Hospital; Västervik Hospital; Kristiansund Hospital; Falu Lasarett Röntgen; Eskilstuna Lasarettet; Sunderbyn Hospital; Lasarett Gävle; Department of Surgery, Lasarettet, Motala, Sweden; Department of Surgery, Lasarettet, Mölndal, Sweden; Department of Surgery, Lasarettet, Norrköping, Sweden; Department of Surgery, Lasarettet, Nyköping, Sweden; Department of Surgery, Lasarettet, Skellefteå, Sweden; Department of Surgery, Kärnsjukhuset, Skövde, Sweden; Department of Surgery, S:t Görans Sjukhus, Stockholm, Sweden; Department of Surgery, Södersjukhuset, Stockholm, Sweden; Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg, Sweden; Department of Surgery, Lasarettet, Växjö, Sweden; Department of Surgery, Lasarettet, Örebro, Sweden; Department of Surgery, Lasarettet, Östersund, Sweden; Department of Vascular Surgery, Sykehuset, Kolding, Denmark
• Investigators: Principal Investigator: Fredrik BG Lundgren, MD, PhD, Department of CardioVascular Surgery, University Hospital, Linköping, Sweden

Study record dates

Study Major Dates

• Study Start: January 1, 1995
• Primary Completion (Actual): June 1, 1998
• Study Completion (Actual): June 1, 1998

Study Registration Dates

• First Submitted: January 27, 2011
• First Submitted That Met QC Criteria: January 27, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 27, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Graft patency; Limb salvage
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: SCAMICOS