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BEnefit of Arterial Preparation by LONGitudinal Scoring

NCT03721939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease

Interventions

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.

Sponsors & Collaborators

  • VentureMed Group Inc.

    lead INDUSTRY

Principal Investigators

  • Daniel Periard, MD · Fribourg Cantonal Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2023-01-25
Completion
2024-03-04
FDA Device
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721939 on ClinicalTrials.gov