BEnefit of Arterial Preparation by LONGitudinal Scoring (BELONG)

• ClinicalTrials.gov Identifier: NCT03721939
• Recruitment Status: Unknown
• First Posted: October 26, 2018
• Last Update Posted: April 14, 2021
• Sponsor: VentureMed Group Inc.
• Information provided by (Responsible Party): VentureMed Group Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease	Device: FLEX Scoring Catheter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BEnefit of Arterial Preparation by LONGitudinal Scoring Before Paclitaxel Eluting Balloon Angioplasty of the Superficial Femoral and Popliteal Artery
• Actual Study Start Date: October 24, 2018
• Estimated Primary Completion Date: December 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Absence of clinically driven target lesion revascularization (CDTLR) at 12 months [ Time Frame: 12 months ]
2. Occurrence of death from cardiovascular origin [ Time Frame: 12 months ]
3. Occurrence of major amputation of target limb [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan) [ Time Frame: 3 and 12 months ]
2. Absence of CDTLR [ Time Frame: 3 months ]
3. Absence of major amputation [ Time Frame: 3 and 12 months ]
4. Change in ankle brachial index (ABI) [ Time Frame: 3 and 12 months ]
5. Change in Rutherford class of symptom [ Time Frame: 3 and 12 Months ]
6. Technical success of the scoring procedure [ Time Frame: Average of 2 hours ]
7. Proportion of luminal gain [ Time Frame: Average of 2 hours ]
8. Occurrence of dissection [ Time Frame: Average of 2 hours ]
9. Proportion of stent implantation [ Time Frame: Average of 2 hours ]

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Jill Schweiger; 763-296-2021; Jschweiger@venturemedgroup.com

Locations

Switzerland

Hôpital Cantonal de Fribourg; Recruiting

Fribourg, Switzerland

Contact: Periard, MD

Principal Investigator: Daniel Periard, MD

Sub-Investigator: Rolf Engelberger, MD

Sponsors and Collaborators

VentureMed Group Inc.

Investigators

• Principal Investigator: Daniel Periard, MD; Fribourg Cantonal Hospital

More Information

• Responsible Party: VentureMed Group Inc.
• ClinicalTrials.gov Identifier: NCT03721939
• Other Study ID Numbers: BELONG Study
• First Posted: October 26, 2018
• Last Update Posted: April 14, 2021
• Last Verified: October 2020

• 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

Additional relevant MeSH terms:

Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases