RecruitingNCT07010354

An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow

An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System

Sponsor

Bentley InnoMed GmbH

Enrollment

100 participants

Start Date

Aug 8, 2025

Study Type

OBSERVATIONAL

Conditions

Iliac Artery Stenosis Iliac Artery Occlusion

Summary

This international, observational multi-centre study of the device BFI will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects pursuant to the Intended Purpose.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Stenting for people with iliac artery occlusion and iliac artery stenosis. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEStenting

Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent

Locations(5)

AZORG

Aalst, Belgium

AZ Sint Blasius

Dendermonde, Belgium

Ziekenhuis Oost-Limburg AV

Genk, Belgium

CHU de Liège

Liège, Belgium

EOC - Ente Ospedaliero Cantonale

Lugano, Canton Ticino, Switzerland

View Full Details on ClinicalTrials.gov

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NCT07010354