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. 2017 Apr 3;2017(4):CD002000. doi: 10.1002/14651858.CD002000.pub3

BEST‐CLI trial.

Trial name or title Best Endovascular Versus Best Surgical Therapy in Patients With Critical Limb Ischemia
Methods Allocation: randomised
 Endpoint classification: efficacy study
 Intervention model: parallel assignment
 Masking: open label
 Primary purpose: treatment
Participants Individuals with PAD presenting with CLI
Interventions Open surgical revascularization versus endovascular revascularization
Outcomes Primary outcome measures:
  • Time to major adverse limb event or death, whichever occurs first


Secondary outcome measures:
  • Time to reintervention of the index leg, amputation of the index leg, or death, whichever occurs first

  • Number of reinterventions in the index leg

  • Time to all‐cause mortality

  • Change in VascuQoL score

  • Change in EuroQoL EQ‐5D score

  • Treatment‐associated costs

  • Major adverse cardiovascular events

  • Proportion of subjects with at least one perioperative complication

Starting date August 2014
Contact information Angela S Knox, MS, PMP aknox@neriscience.com
Notes NCT02060630
Sponsors and Collaborators: New England Research Institutes; Brigham and Women's Hospital; Massachusetts General Hospital; Boston Medical Center; National Heart, Lung, and Blood Institute (NHLBI)