Scandinavian Miller Collar Study (SCAMICOS)

This study has been completed.
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
Department of Surgery, Lasarettet, Västervik, Sweden
Department of Surgery, Lasarettet, Västerås, 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
Rigshospitalet, Denmark
Aalborg Universityhospital
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01285986
First received: January 27, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention
Critical Limb Ischemia
Procedure: Vein collar at the distal anastomosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Scandinavian Miller Collar Study

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Primary graft patency [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
    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:
  • Secondary Patency [ Time Frame: Up to five years ] [ Designated as safety issue: No ]
    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.


Enrollment: 352
Study Start Date: January 1995
Study Completion Date: June 1998
Primary Completion Date: June 1998 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Department of Surgery, Lasarettet, Västervik, Sweden
Department of Surgery, Lasarettet, Västerås, 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
Rigshospitalet, Denmark
Aalborg Universityhospital
Investigators
Principal Investigator: Fredrik BG Lundgren, MD, PhD Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
  More Information

No publications provided

Responsible Party: Fredrik Lundgren, Department od Cardiovascular Surgery, University Hospital, Linköping, Sweden
ClinicalTrials.gov Identifier: NCT01285986     History of Changes
Other Study ID Numbers: SCAMICOS
Study First Received: January 27, 2011
Last Updated: January 27, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Graft patency
Limb salvage

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014