Back to resultsScandinavian Miller Collar Study (SCAMICOS)
Primary Purpose
Critical Limb Ischemia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Vein collar at the distal anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Graft patency, Limb salvage
Eligibility Criteria
Inclusion Criteria:
- Critical limb ischemia
- Need for bypass surgery
Exclusion Criteria:
- Can not participate in follow-up
- Has suitable saphenous vein
Sites / Locations
- Department of CardioVascular Surgery, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vein collar at distal anastomosis
No vein collar at the distal anastomosis
Arm Description
Vein collar at the distal anastomosis
No vein collar at the distal anastomosis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01285986
First Posted
January 27, 2011
Last Updated
January 27, 2011
Sponsor
University Hospital, Linkoeping
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 University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01285986
Brief Title
Scandinavian Miller Collar Study
Acronym
SCAMICOS
Official Title
Scandinavian Miller Collar Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 1995 (undefined)
Primary Completion Date
June 1998 (Actual)
Study Completion Date
June 1998 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Linkoeping
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 University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
Graft patency, Limb salvage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
352 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vein collar at distal anastomosis
Arm Type
Experimental
Arm Description
Vein collar at the distal anastomosis
Arm Title
No vein collar at the distal anastomosis
Arm Type
Experimental
Arm Description
No vein collar at the distal anastomosis
Intervention Type
Procedure
Intervention Name(s)
Vein collar at the distal anastomosis
Intervention Description
Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
Primary Outcome Measure Information:
Title
Primary graft patency
Description
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.
Time Frame
Up to five years
Secondary Outcome Measure Information:
Title
Secondary Patency
Description
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.
Time Frame
Up to five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Critical limb ischemia
Need for bypass surgery
Exclusion Criteria:
Can not participate in follow-up
Has suitable saphenous vein
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fredrik BG Lundgren, MD, PhD
Organizational Affiliation
Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of CardioVascular Surgery, University Hospital
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
12. IPD Sharing Statement
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Scandinavian Miller Collar Study
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