Table 4.

Efficacy, safety, and functional outcomes

Variable	(n = 35)
6‐month primary efficacy outcome
Freedom from CD‐TLR, n (%)	27/28 (96.4)
Primary patency, n (%)	25/28 (89.3)
6‐month primary safety outcome
Death, n (%)	2 (5.7)
Thrombosis, n (%)	0
Major amputation in target limb (%)	0
Ankle‐brachial index
Screening	1.0 ± 0.38
	1.0 [0.18–2.72]
3 months	1.1 ± 0.21
	1.1 [0.66–1.57]
6 months	1.0 ± 0.28
	1.1 [0.48–1.50]
Rutherford score
Screening	3.6 ± 0.7
	4 [2–5]
3 months	1.4 ± 1.2
	1 [0–4]
6 months	1.8 ± 1.1
	2 [0–4]

Abbreviation: CD‐TLR, clinically driven target lesion revascularization.