Scandinavian Miller Collar Study (SCAMICOS)
This study has been completed.
Sponsor:
University Hospital, Linkoeping
Collaborators:
Department of Surgery, Lasarettet, Boden, Sweden
Department of Surgery, Lasarettet, Borås, Sweden
Department of Surgery, Lasarettet, Eskilstuna, Sweden
Department of Surgery, Lasarettet, Falun, Sweden
Department of Surgery, Sahlgrenska sjukhuset, Göteborg, Sweden
Department of Surgery, Östra sjukhuset, Göteborg, Sweden
Department of Surgery, Lasarettet, Gävle, Sweden
Department of Surgery, Lasarettet, Helsingborg, Sweden
Department of Surgery, Lasarettet, Kalmar, Sweden
Department of Surgery, Lasarettet, Karlstad, Sweden
Department of Surgery, Lasarettet, Kristianstad, Sweden
Department of Vascular Surgery, Universitetssjukhuset, Linköping, Sweden
Department of Surgery, Universitetssjukhuset, Lund, Sweden
Department of Surgery, Universitetssjukhuset, Malmö, Sweden
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
Department of Vascular Surgery, Rikshospitalet, København, Denmark
Department of Vascular Surgery, Sykehuset, Aalborg, Denmark
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
| Tracking Information | |||||
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| First Received Date ICMJE | January 27, 2011 | ||||
| Last Updated Date | January 27, 2011 | ||||
| Start Date ICMJE | January 1995 | ||||
| Primary Completion Date | June 1998 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Scandinavian Miller Collar Study | ||||
| Official Title ICMJE | Scandinavian Miller Collar Study | ||||
| 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 |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Critical Limb Ischemia | ||||
| Intervention ICMJE | Procedure: Vein collar at the distal anastomosis
Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 352 | ||||
| Completion Date | June 1998 | ||||
| Primary Completion Date | June 1998 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 20 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01285986 | ||||
| Other Study ID Numbers ICMJE | SCAMICOS | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Fredrik Lundgren, Department od Cardiovascular Surgery, University Hospital, Linköping, Sweden | ||||
| Study Sponsor ICMJE | University Hospital, Linkoeping | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University Hospital, Linkoeping | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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