Scandinavian Miller Collar Study
- Conditions
- Critical Limb Ischemia
- Registration Number
- NCT01285986
- Lead Sponsor
- University Hospital, Linkoeping
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
- Critical limb ischemia
- Need for bypass surgery
- Can not participate in follow-up
- Has suitable saphenous vein
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Department of CardioVascular Surgery, University Hospital
🇸🇪Linköping, Sweden
Department of CardioVascular Surgery, University Hospital🇸🇪Linköping, Sweden