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, Link√∂ping, Sweden,
  • Overall Official(s)
    • Fredrik BG Lundgren, MD, PhD, Principal Investigator, Department of Cardiovascular Surgery, University Hospital, Link√∂ping, Sweden

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