BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

VentureMed

Status: Unknown

Conditions: Peripheral Arterial Disease

Treatments: Device: FLEX Scoring Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03721939

BELONG Study

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

FLEX Scoring Catheter plus DEB

Experimental group

Description:

The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion.

Treatment:

Device: FLEX Scoring Catheter