CVIR Endovascular

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

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

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