Critical Limb IschemiaSCAMICOSNCT01285986
Scandinavian Miller Collar Study
A study testing Vein collar at the distal anastomosis in people with Critical Limb Ischemia, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial 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 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?
- Vein collar at the distal anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteSweden
- 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 not participate in follow-up
- Has suitable saphenous vein
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of CardioVascular Surgery, University Hospital
Linköping, 581 85
About this study
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
- Conditions
- Critical Limb Ischemia
- Being tested
- Vein collar at the distal anastomosis
- Keywords
- Graft patency, Limb salvage
- 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.
Vein collar at the distal anastomosisProcedure or surgery
Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Vein collar at distal anastomosis | Experimental | Vein collar at the distal anastomosis Receives: Procedure: Vein collar at the distal anastomosis |
| No vein collar at the distal anastomosis | Experimental | No vein collar at the distal anastomosis Receives: Procedure: Vein collar at the distal anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary graft patency
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.
Measured: Up to five years
Secondary outcomes (1)
Secondary Patency
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.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 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
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Sunderbyn Hospital, Borås Lasarett, Eskilstuna Lasarettet, Falu Lasarett Röntgen, Sahlgrenska University Hospital, Lasarett Gävle, Helsingborgs Hospital, Kalmar County Hospital, Karlstad Central Hospital, Kristiansund Hospital, Lund University Hospital, Malmö University, Department of Surgery, Lasarettet, Motala, Sweden, Molndal Hospital, Vrinnevi Hospital, 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, Västervik Hospital, Region Västmanland, 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, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital
- Investigators
- Fredrik BG Lundgren, MD, PhD, Principal investigator, Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285986
- Sponsor's protocol ID
- SCAMICOS
- Acronym
- SCAMICOS
- Status last verified
- Jan 2011
- First submitted
- 27 Jan 2011
- Last updated
- 28 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Miller Collar Study
- ClinicalTrials.gov ID
- NCT01285986
- Acronym / sponsor ID
- SCAMICOS / SCAMICOS
- Conditions
- Critical Limb Ischemia
- Keywords
- Graft patency, Limb salvage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Sunderbyn Hospital, Borås Lasarett, Eskilstuna Lasarettet, Falu Lasarett Röntgen, Sahlgrenska University Hospital, Lasarett Gävle, Helsingborgs Hospital, Kalmar County Hospital, Karlstad Central Hospital, Kristiansund Hospital, Lund University Hospital, Malmö University, Department of Surgery, Lasarettet, Motala, Sweden, Molndal Hospital, Vrinnevi Hospital, 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, Västervik Hospital, Region Västmanland, 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, Copenhagen University Hospital, Rigshospitalet, Aalborg University Hospital
- Study start
- Jan 1995
- Primary completion
- Jun 1998 (actual)
- Study completion
- Jun 1998 (actual)
- First posted
- 28 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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vein collar at distal anastomosis | Experimental | Procedure: Vein collar at the distal anastomosisVein collar at the distal anastomosis |
| No vein collar at the distal anastomosis | Experimental | Procedure: Vein collar at the distal anastomosisNo vein collar at the distal anastomosis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Critical limb ischemia
- Need for bypass surgery
Key exclusion criteria (2 listed)
- Can not 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 |
|---|---|---|
| Vein collar at the distal anastomosisVein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis | Procedure or surgery | No vein collar at the distal anastomosis, Vein collar at distal anastomosis |
Primary outcome
Primary graft patency
Time frame: Up to five years
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.
1 secondary outcome
Secondary Patency
Time frame: Up to five years
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 28 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, MD, PhD principal investigator
Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein collar at the distal anastomosis in people with Critical Limb Ischemia, run by University Hospital, Linkoeping at 1 site in Sweden.
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 2 inclusion and 2 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 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (time frame: Up to five years). 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 28 Jan 2011.