Swedish External Support Study

Overview

Randomized study to evaluate the effect of adding external support 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.

Full Title of Study: “Swedish External Support Study is Randomized Trial of the Effect of External Support of PTFE-grafts for Bypass to Below Knee Arteries.”

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: External support
    • Bypass surgery with externally supported graft

Arms, Groups and Cohorts

  • Experimental: External support
    • Bypass graft with external support
  • Experimental: No external support
    • Bypass with graft without external support

Clinical Trial Outcome Measures

Primary Measures

  • primary graft patency

Secondary Measures

  • limb salvage

Participating in This Clinical Trial

Inclusion Criteria

Critical limb ischemia Need for bypass surgery

Exclusion Criteria

Can 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
    • Lasarettet Boden
  • Provider of Information About this Clinical Study
    • Fredrik Lundgren, Department of CardioVascylar Surgery, Universityhospital, Link√∂ping, Sweden
  • Overall Official(s)
    • Fredrik BG Lundgren, PhD, MD, Principal Investigator, Department of CardioVascular Surgery, University Hospital, Link√∂ping, Sweden

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