Scandinavian Miller Collar Study (SCAMICOS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Critical Limb Ischemia	Procedure: Vein collar at the distal anastomosis	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	352 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Scandinavian Miller Collar Study
Study Start Date :	January 1995
Actual Primary Completion Date :	June 1998
Actual Study Completion Date :	June 1998

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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; 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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Primary graft patency [ Time Frame: 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 :

1. Secondary Patency [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Critical limb ischemia
• Need for bypass surgery

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University Hospital, Linkoeping

Sunderbyn Hospital

Borås Lasarett

Eskilstuna Lasarettet

Falu Lasarett Röntgen

Sahlgrenska University Hospital, Sweden

Lasarett Gävle

Helsingborgs Hospital

Kalmar County Hospital

Karlstad Central Hospital

Kristiansund Hospital

Lund University Hospital

Malmö University

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

Uppsala University Hospital

Västervik Hospital

Region Västmanland

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

Rigshospitalet, Denmark

Aalborg Universitetshospital

Investigators

Principal Investigator:	Fredrik BG Lundgren, MD, PhD	Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Fredrik Lundgren, Department od Cardiovascular Surgery, University Hospital, Linköping, Sweden
ClinicalTrials.gov Identifier:	NCT01285986 History of Changes
Other Study ID Numbers:	SCAMICOS
First Posted:	January 28, 2011
Last Update Posted:	January 28, 2011
Last Verified:	January 2011

Keywords provided by University Hospital, Linkoeping:

Graft patency; Limb salvage

Additional relevant MeSH terms:

Ischemia; Pathologic Processes