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Table 2 Time windows

From: PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient

Visit Target Interval Minimum Maximum
Two (2) weeks 15 days ± 5 days 10 days 20 days
One (1) month 30 days ± 7 days 23 days 37 days
Two (2) months 60 days ± 10 days 50 days 70 days
Three (3) months 90 days ± 14 days 76 days 104 days
Six (6) months 180 days ± 14 days 166 days 194 days
Nine (9) months 270 days ± 14 days 256 days 284 days
Twelve (12) months 360 days ± 28 days 332 days 388 days
  1. All variables will be recorded on electronic Case Report Forms (eCRFs) specifically designed for the study and provided by LimFlow SA to the investigational centers. Collected variables will be analyzed using IBM SPSS statistics software, version 17 or later