Swedish External Support Study
SWEXSUS
1 other identifier
interventional
334
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1995
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1995
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedJanuary 10, 2011
January 1, 2011
3.4 years
January 7, 2011
January 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
primary graft patency
Secondary Outcomes (1)
limb salvage
Study Arms (2)
External support
EXPERIMENTALBypass graft with external support
No external support
EXPERIMENTALBypass with graft without external support
Interventions
Bypass surgery with externally supported graft
Eligibility Criteria
You may qualify if:
- Critical limb ischemia Need for bypass surgery
You may not qualify if:
- Can participate in follow-up Has suitable saphenous vein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Linkoepinglead
- Lasarettet Bodencollaborator
- Borås Lasarettcollaborator
- Eskilstuna Lasarettetcollaborator
- Falu Lasarett Röntgencollaborator
- Department of Surgery, Sahlgrenska sjukhuset, Göteborgcollaborator
- Department of Surgery, Östra sjukhuset, Göteborgcollaborator
- Lasarett Gävlecollaborator
- Helsingborgs Hospitalcollaborator
- Kalmar County Hospitalcollaborator
- Karlstad Central Hospitalcollaborator
- Kristiansund Hospitalcollaborator
- Lund University Hospitalcollaborator
- Malmö Universitycollaborator
- Department of Surgery, Lasarettet, Motalacollaborator
- Department of Surgery, Lasarettet, Mölndalcollaborator
- Department of Surgery, Lasarettet, Norrköpingcollaborator
- Department of Surgery, Lasarettet, Nyköpingcollaborator
- Department of Surgery, Lasarettet, Skellefteåcollaborator
- Department of Surgery, Kärnsjukhuset, Skövdecollaborator
- Department of Surgery, S:t Görans Sjukhus, Stockholmcollaborator
- Department of Surgery, Södersjukhuset, Stockholmcollaborator
- Department of Surgery, Norra Älvsborgs Länssjukhus, Trollhättan-Vänersborgcollaborator
- Uppsala University Hospitalcollaborator
- Västervik Hospitalcollaborator
- Region Västmanlandcollaborator
- Department of Surgery, Lasarettet, Växjöcollaborator
- Department of Surgery, Lasarettet, Örebrocollaborator
- Department of Surgery, Lasarettet, Östersundcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fredrik BG Lundgren, PhD, MD
Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
January 1, 1995
Primary Completion
June 1, 1998
Study Completion
June 1, 1998
Last Updated
January 10, 2011
Record last verified: 2011-01