Swedish External Support Study (SWEXSUS)
January 7, 2011 updated by: University Hospital, Linkoeping
Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
334
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Critical limb ischemia Need for bypass surgery
Exclusion Criteria:
Can participate in follow-up Has suitable saphenous vein
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: External support
Bypass graft with external support
|
Bypass surgery with externally supported graft
|
|
Experimental: No external support
Bypass with graft without external support
|
Bypass surgery with externally supported graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
primary graft patency
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
limb salvage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fredrik BG Lundgren, PhD, MD, Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1995
Primary Completion (Actual)
June 1, 1998
Study Completion (Actual)
June 1, 1998
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (Estimate)
January 10, 2011
Study Record Updates
Last Update Posted (Estimate)
January 10, 2011
Last Update Submitted That Met QC Criteria
January 7, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWEXSUS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.