The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.
Hôpital Cantonal de Fribourg
Fribourg, Switzerland
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
Time frame: 12 months
Occurrence of death from cardiovascular origin
Time frame: 12 months
Occurrence of major amputation of target limb
Time frame: 12 months
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
Time frame: 3 and 12 months
Absence of CDTLR
Time frame: 3 months
Absence of major amputation
Time frame: 3 and 12 months
Change in ankle brachial index (ABI)
Time frame: 3 and 12 months
Change in Rutherford class of symptom
Time frame: 3 and 12 Months
Technical success of the scoring procedure
Time frame: Average of 2 hours
Proportion of luminal gain
Time frame: Average of 2 hours
Occurrence of dissection
Time frame: Average of 2 hours
Proportion of stent implantation
Time frame: Average of 2 hours
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