BEnefit of Arterial Preparation by LONGitudinal Scoring

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT03721939
• Date of registration: 21/10/2018
• Prospective Registration: Yes
• Primary sponsor: VentureMed Group Inc.
• Public title: BEnefit of Arterial Preparation by LONGitudinal Scoring BELONG
• Scientific title: BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
• Date of first enrolment: October 24, 2018
• Target sample size: 150
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03721939
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Daniel Periard, MD
• Affiliation: Fribourg Cantonal Hospital

• Name: Periard, MD

• Name: Jill Schweiger

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Peripheral Arterial Disease

Intervention(s)

Device: FLEX Scoring Catheter

Primary Outcome(s)

Occurrence of death from cardiovascular origin [Time Frame: 12 months]

Occurrence of major amputation of target limb [Time Frame: 12 months]

Absence of clinically driven target lesion revascularization (CDTLR) at 12 months [Time Frame: 12 months]

Secondary Outcome(s)

Proportion of luminal gain [Time Frame: Average of 2 hours]

Technical success of the scoring procedure [Time Frame: Average of 2 hours]

Absence of major amputation [Time Frame: 3 and 12 months]

Change in Rutherford class of symptom [Time Frame: 3 and 12 Months]

Occurrence of dissection [Time Frame: Average of 2 hours]

Change in ankle brachial index (ABI) [Time Frame: 3 and 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]

Proportion of stent implantation [Time Frame: Average of 2 hours]

Secondary ID(s)

BELONG Study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors