|
Composite safety endpoint*
|
91.3 (21/23)
|
87.5 (21/24)
|
1.000
|
|
Device- and procedure-related death within 30 days
|
0.0 (0/23)
|
3.7 (1/27)
|
1.000
|
|
Major target limb amputation within 9 months
|
0.0 (0/23)
|
0.0 (0/23)
|
>0.999
|
|
CD-TLR within 9 months◊
|
8.7 (2/23)
|
8.7 (2/23)
|
1.000
|
|
Major adverse events up to 9 months‡
|
13.0 (3/23)
|
16.0 (4/25)
|
1.000
|
|
Death, all-cause
|
4.3 (1/23)
|
8.0 (2/25)
|
1.000
|
|
Death, cardiovascular-related
|
4.3 (1/23)
|
8.0 (2/25)
|
1.000
|
|
Major target limb amputation
|
0.0 (0/23)
|
0.0 (0/23)
|
>0.999
|
|
CD-TLR
|
8.7 (2/23)
|
8.7 (2/23)
|
1.000
|
|
Mechanically driven TLR within 37 days§
|
4.3 (1/23)
|
0.0 (0/26)
|
0.469
|
|
Any TLR
|
8.7 (2/23)
|
16.7 (4/24)
|
0.666
|
|
CD-TVR¶
|
8.7 (2/23)
|
13.0 (3/23)
|
1.000
|
|
Any TVR
|
8.7 (2/23)
|
20.8 (5/24)
|
0.416
|
|
Thrombosis at the target lesion(s)
|
4.3 (1/23)
|
4.2 (1/24)
|
1.000
|
|
Values are % (n/N). *The composite safety endpoint is a composite of freedom from device- and procedure-related mortality within 30 days, and freedom from major target limb amputation and freedom from CD-TLR within 9 months after the index procedure. ◊CD-TLR is defined as any TLR of the target lesion with restenosis >70% (confirmed by angiography) associated with at least one of the following: reoccurrence of ischaemic rest pain, worsening of pre-existing wounds, or occurrence of a new wound(s). ‡Major adverse events defined as a composite of all-cause mortality, major target limb amputation, and CD-TLR. §Mechanically driven TLR is defined as any TLR due to a flow-limiting dissection or flow-limiting thrombosis at the target lesion that occurs within 37 days post procedure documented by a peak systolic velocity ratio >2.4. ¶CD-TVR is defined as any TVR of the target vessel associated with at least one of the following: reoccurrence of ischaemic rest pain, worsening of pre-existing wounds, or occurrence of a new wound(s). CD-TLR: clinically driven target lesion revascularisation; CD-TVR: clinically driven target vessel revascularisation; DCB: drug-coated balloon; PTA; percutaneous transluminal angioplasty; TLR: target lesion revascularisation; TVR: target vessel revascularisation
|
