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

Recruiting now

Conditions studied: Iliac Artery Stenosis, Iliac Artery Occlusion

In brief

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.

Key facts

Study ID

NCT07010354

Run by

Bentley InnoMed GmbH

People needed

100

Starts

2025-08-08

Expected to finish

2031-12-31

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an indication for permanent intraluminal placement in iliac arteries for restoring and improving the patency impaired by arteriosclerosis or other stenoses that may be treated by stenting according to the IFU of the BFI
• Patient is capable and willing to sign an informed consent
• Patients ≥18 years of age at the time of consent

You may not qualify if…

• Patients with any contraindication according to the IFU
• Previous stenting of the target vessel

Where it is running

• AZORG — Aalst, Belgium (enrolling)
• AZ Sint Blasius — Dendermonde, Belgium (enrolling)
• Ziekenhuis Oost-Limburg AV — Genk, Belgium (enrolling)
• CHU de Liège — Liège, Belgium (enrolling)
• EOC - Ente Ospedaliero Cantonale — Lugano, Canton Ticino, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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