Critical Limb Ischemia
Conditions
Keywords
Graft patency, Limb salvage
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
Interventions
PROCEDUREVein collar at the distal anastomosis
Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
Sponsors
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
Department of Surgery, Lasarettet, Mölndal, Sweden
Department of Surgery, Lasarettet, Norrköping, Sweden
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
Rigshospitalet, Denmark
Aalborg University Hospital
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Critical limb ischemia * Need for bypass surgery
Exclusion criteria
* Can not participate in follow-up * Has suitable saphenous vein
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary graft patency | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Patency | Up to five years | 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. |
Countries
Sweden
Outcome results
None listed