BEnefit of Arterial Preparation by LONGitudinal Scoring

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: FLEX Scoring Catheter

• Registration Number: NCT03721939
• Lead Sponsor: VentureMed Group Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-21
• Study Start: 2018-10-24
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Primary Completion: 2023-01-25
• Study Completion: 2024-03-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLEX Scoring Catheter plus DEB	FLEX Scoring Catheter	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Hôpital Cantonal de Fribourg; 🇨🇭 Fribourg, Switzerland