Scandinavian Miller Collar Study
Overview
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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 1998
Interventions
- Procedure: Vein collar at the distal anastomosis
- Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
Arms, Groups and Cohorts
- Experimental: Vein collar at distal anastomosis
- Vein collar at the distal anastomosis
- Experimental: No vein collar at the distal anastomosis
- No vein collar at the distal anastomosis
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Secondary Patency
- Time Frame: 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.
Participating in This Clinical Trial
Inclusion Criteria
- Critical limb ischemia – Need for bypass surgery Exclusion Criteria:
- Can not participate in follow-up – Has suitable saphenous vein
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University Hospital, Linkoeping
- Collaborator
- Sunderbyn Hospital
- Provider of Information About this Clinical Study
- Fredrik Lundgren, Department od Cardiovascular Surgery, University Hospital, Linköping, Sweden,
- Overall Official(s)
- Fredrik BG Lundgren, MD, PhD, Principal Investigator, Department of Cardiovascular Surgery, University Hospital, Linköping, Sweden
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