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BEnefit of Arterial Preparation by LONGitudinal Scoring

NCT ID: NCT03721939

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-24

Study Completion Date

2024-03-04

Brief Summary

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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

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

FLEX Scoring Catheter

Intervention Type DEVICE

Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.

Interventions

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FLEX Scoring Catheter

Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VentureMed Group Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Periard, MD

Role: PRINCIPAL_INVESTIGATOR

Fribourg Cantonal Hospital

Locations

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Hôpital Cantonal de Fribourg

Fribourg, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BELONG Study

Identifier Type: -

Identifier Source: org_study_id