BEnefit of Arterial Preparation by LONGitudinal Scoring

Peripheral Arterial Disease Clinical Trial

— BELONG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03721939
• Other study ID #: BELONG Study
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2018
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: VentureMed Group Inc.
• Contact: Jill Schweiger
• Phone: 763-296-2021
• Email: Jschweiger[@]venturemedgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Hôpital Cantonal de Fribourg	Fribourg

Sponsors (1)

Lead Sponsor	Collaborator
VentureMed Group Inc.

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of clinically driven target lesion revascularization (CDTLR) at 12 months		12 months
Primary	Occurrence of death from cardiovascular origin		12 months
Primary	Occurrence of major amputation of target limb		12 months
Secondary	Primary patency of the treated lesion (defined by PSVR = 2.5 at duplex scan)		3 and 12 months
Secondary	Absence of CDTLR		3 months
Secondary	Absence of major amputation		3 and 12 months
Secondary	Change in ankle brachial index (ABI)		3 and 12 months
Secondary	Change in Rutherford class of symptom		3 and 12 Months
Secondary	Technical success of the scoring procedure		Average of 2 hours
Secondary	Proportion of luminal gain		Average of 2 hours
Secondary	Occurrence of dissection		Average of 2 hours
Secondary	Proportion of stent implantation		Average of 2 hours