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

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

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study details
    Iliac Artery Stenosis
    Iliac Artery Occlusion

NCT07010354

Bentley InnoMed GmbH

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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