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Scandinavian Miller Collar Study (SCAMICOS)

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ClinicalTrials.gov Identifier: NCT01285986
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : January 28, 2011
Sponsor:
Collaborators:
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
Information provided by:
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

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

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

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



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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285986


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

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    Key Record Dates
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