BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery

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 Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: FLEX Scoring Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Schweiger; Phone Number: 763-296-2021; Email: jschweiger@venturemedgroup.com

Study Locations

• Switzerland
  • Fribourg, Switzerland
    • Recruiting
    • Hôpital Cantonal de Fribourg
    • Contact: Periard, MD
    • Principal Investigator: Daniel Periard, MD
    • Sub-Investigator: Rolf Engelberger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FLEX Scoring Catheter plus DEB; 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.	Device: FLEX Scoring Catheter; Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence of clinically driven target lesion revascularization (CDTLR) at 12 months	12 months
Occurrence of death from cardiovascular origin	12 months
Occurrence of major amputation of target limb	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan)	3 and 12 months
Absence of CDTLR	3 months
Absence of major amputation	3 and 12 months
Change in ankle brachial index (ABI)	3 and 12 months
Change in Rutherford class of symptom	3 and 12 Months
Technical success of the scoring procedure	Average of 2 hours
Proportion of luminal gain	Average of 2 hours
Occurrence of dissection	Average of 2 hours
Proportion of stent implantation	Average of 2 hours

Collaborators and Investigators

• Sponsor: VentureMed Group Inc.
• Investigators: Principal Investigator: Daniel Periard, MD, Fribourg Cantonal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 21, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BELONG Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes