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
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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 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 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 |
Inclusion Criteria:
- Critical limb ischemia
- Need for bypass surgery
Exclusion Criteria:
- Can not participate in follow-up
- Has suitable saphenous vein

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