NCT01285986CompletedNot Applicable
Scandinavian Miller Collar Study
University Hospital, Linkoeping2 sites in 1 country352 target enrollmentStarted: January 1, 1995Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 352
- Locations
- 2
- Primary Endpoint
- Primary graft patency
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Critical limb ischemia
- •Need for bypass surgery
Exclusion Criteria
- •Can not participate in follow-up
- •Has suitable saphenous vein
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Secondary Patency(Up to five years)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Swedish External Support StudyCritical Limb IschemiaNCT01273740University Hospital, Linkoeping334
Completed
Not Applicable
A Clinical Trial on No-touch Vein Graft (NT-graft) in Coronary SurgeryIschemic Heart DiseaseNCT03501303Uppsala University902
Unknown
Not Applicable
Role of Double Cuffed PTFE Arteriovenous Grafts in Enhancing Long-term Patency in Hemodialysis Patients (Extended Poly Tetra Fluoro Ethylene)End Stage Renal DiseaseNCT03405233Mansoura University220
Completed
Not Applicable
Vascular Access for Hemodialysis and InflammationVascular Access for Hemodialysis and InflammationNCT00850707IRCCS Azienda Ospedaliero-Universitaria di Bologna458
Unknown
Not Applicable
Use of the Skin Glue in the Placement of Central Venous Catheters Port a CatchCentral Venous CatheterNCT03801811University of Parma100