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Swedish External Support Study (SWEXSUS)
This study has been completed.
Sponsor:
University Hospital, Linkoeping
Collaborators:
Lasarettet Boden
Borås Lasarett
Eskilstuna Lasarettet
Falu Lasarett Röntgen
Department of Surgery, Sahlgrenska sjukhuset, Göteborg
Department of Surgery, Östra sjukhuset, Göteborg
Lasarett Gävle
Helsingborgs Hospital
Kalmar County Hospital
Karlstad Central Hospital
Kristiansund Hospital
Lund University Hospital
Malmö University
Department of Surgery, Lasarettet, Motala
Department of Surgery, Lasarettet, Mölndal
Department of Surgery, Lasarettet, Norrköping
Department of Surgery, Lasarettet, Nyköping
Department of Surgery, Lasarettet, Skellefteå
Department of Surgery, Kärnsjukhuset, Skövde
Department of Surgery, S:t Görans Sjukhus, Stockholm
Department of Surgery, Södersjukhuset, Stockholm
Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborg
Uppsala University Hospital
Västervik Hospital
Landstinget Västmanland
Department of Surgery, Lasarettet, Växjö
Department of Surgery, Lasarettet, Örebro
Department of Surgery, Lasarettet, Östersund
Information provided by:
University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01273740
First received: January 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 7, 2011 | |||
| Last Updated Date | January 7, 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 | |||
| Original Primary Outcome Measures ICMJE | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures ICMJE |
limb salvage | |||
| 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 | Swedish External Support Study | |||
| Official Title ICMJE | Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries. | |||
| Brief Summary | Randomized study to evaluate the effect of adding external support 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase | Not Provided | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Critical Limb Ischemia | |||
| Intervention ICMJE | Procedure: External support
Bypass surgery with externally supported graft |
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| Study Arms |
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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 | 334 | |||
| Completion Date | June 1998 | |||
| Primary Completion Date | June 1998 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria: Critical limb ischemia Need for bypass surgery Exclusion Criteria: Can participate in follow-up Has suitable saphenous vein |
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| Sex/Gender |
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| Ages | 20 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01273740 | |||
| Other Study ID Numbers ICMJE | SWEXSUS | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Linköping, Sweden | |||
| Study Sponsor ICMJE | University Hospital, Linkoeping | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | 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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