Critical Limb IschemiaSWEXSUSNCT01273740
Swedish External Support Study
A study testing External support in people with Critical Limb Ischemia, run by University Hospital, Linkoeping.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- External support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- No sites listed yet
- Study dates
- Jan 1995to Jun 1998
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical limb ischemia Need for bypass surgery
Who cannot join
- Can participate in follow-up Has suitable saphenous vein
About this study
Official title: 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- External support
- Keywords
- PTFE bypass, femoro-popliteal, femoro-crural, popliteal arteries, crural arteries, external support, crtical limb ischemia
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External supportProcedure or surgery
Bypass surgery with externally supported graft
| Study group | Role | What they receive |
|---|---|---|
| External support | Experimental | Bypass graft with external support Receives: Procedure: External support |
| No external support | Experimental | Bypass with graft without external support Receives: Procedure: External support |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary graft patency
Secondary outcomes (1)
limb salvage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 1995
- Primary completionJun 1998
- Study completionJun 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- 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, Molndal Hospital, Vrinnevi Hospital, 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, Region Västmanland, Department of Surgery, Lasarettet, Växjö, Department of Surgery, Lasarettet, Örebro, Department of Surgery, Lasarettet, Östersund
- Investigators
- Fredrik BG Lundgren, PhD, MD, Principal investigator, Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273740
- Sponsor's protocol ID
- SWEXSUS
- Acronym
- SWEXSUS
- Status last verified
- Jan 2011
- First submitted
- 7 Jan 2011
- Last updated
- 10 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.
- ClinicalTrials.gov ID
- NCT01273740
- Acronym / sponsor ID
- SWEXSUS / SWEXSUS
- Conditions
- Critical Limb Ischemia
- Keywords
- PTFE bypass, femoro-popliteal, femoro-crural, popliteal arteries, crural arteries, external support, crtical limb ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- 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, Molndal Hospital, Vrinnevi Hospital, 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, Region Västmanland, Department of Surgery, Lasarettet, Växjö, Department of Surgery, Lasarettet, Örebro, Department of Surgery, Lasarettet, Östersund
- Study start
- Jan 1995
- Primary completion
- Jun 1998 (actual)
- Study completion
- Jun 1998 (actual)
- First posted
- 10 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External support | Experimental | Procedure: External supportBypass graft with external support |
| No external support | Experimental | Procedure: External supportBypass with graft without external support |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critical limb ischemia Need for bypass surgery
Key exclusion criteria (1 listed)
- Can participate in follow-up Has suitable saphenous vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External supportBypass surgery with externally supported graft | Procedure or surgery | External support, No external support |
Primary outcome
primary graft patency
1 secondary outcome
limb salvage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik BG Lundgren, PhD, MD principal investigator
Department of CardioVascular Surgery, University Hospital, Linköping, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing External support in people with Critical Limb Ischemia, run by University Hospital, Linkoeping.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
primary graft patency. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.