BEnefit of Arterial Preparation by LONGitudinal Scoring (NCT03721939) | Clinical Trial Compass
CompletedNot Applicable
BEnefit of Arterial Preparation by LONGitudinal Scoring
Switzerland150 participantsStarted 2018-10-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months