Clinical trial NCT03721939: BEnefit of Arterial Preparation by LONGitudinal Scoring
Official title: BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: VentureMed Group Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18-year-old, with symptomatic lower extremity occlusive arterial disease
* Rutherford class of symptom 2 to 5
* Atheromatous ≥ 70 % stenosis or occlusion of SFA and/or PA
* Absence of \> 50% residual stenosis of the run-in vessels at the end of procedure
* Presence of at least one patent (no ≥ 50 % stenosis) run-off tibial or fibular vessel to the foot at the end of procedure
* De novo or restenotic lesions, including in-stent restenosis
* Willingness to participate in the study and signature of informed consent

Exclusion Criteria:

* Renal failure with glomerular filtration rate (GFR) 30 ml/min or below, estimated by the Cockroft-Gault equation.
* Women who are pregnant, lactating, or planning to become pregnant during the duration of the study
* Recent artery thrombosis, at risk of distal embolization during percutaneous procedure
* Previous use of a PCB in the lesion during last 15 months
* Extremely calcified lesions, defined by calcification involving ³ 270° of the artery circumference over ³ 15 cm.
* Sub-intimal recanalization
* Tortuous contra-lateral femoral access with difficult cross-over
* Previous or planned surgery of the target lesion
* High risk of bleeding
* Contra-indication to dual antiplatelet therapy for one month, and/or to single antiplatelet therapy for 1 year
* Allergy to aspirin, clopidogrel or heparin
* Life expectancy less than one year

Primary outcomes:
measure: Absence of clinically driven target lesion revascularization (CDTLR) at 12 months
timeFrame: 12 months
measure: Occurrence of death from cardiovascular origin
timeFrame: 12 months
measure: Occurrence of major amputation of target limb
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)
timeFrame: 3 and 12 months
measure: Absence of CDTLR
timeFrame: 3 months
measure: Absence of major amputation
timeFrame: 3 and 12 months
measure: Change in ankle brachial index (ABI)
timeFrame: 3 and 12 months
measure: Change in Rutherford class of symptom
timeFrame: 3 and 12 Months
measure: Technical success of the scoring procedure
timeFrame: Average of 2 hours
measure: Proportion of luminal gain
timeFrame: Average of 2 hours
measure: Occurrence of dissection
timeFrame: Average of 2 hours
measure: Proportion of stent implantation
timeFrame: Average of 2 hours
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Hôpital Cantonal de Fribourg
Study officials:
affiliation: Fribourg Cantonal Hospital
name: Daniel Periard, MD
role: PRINCIPAL_INVESTIGATOR
References: