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NCT Number: NCT07010354

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

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.

Recruiting

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Key information

Conditions

Iliac Artery Stenosis Iliac Artery Occlusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZORG, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stenting

Device

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

Primary outcomes

  1. Primary patency rate

    Time frame: 12 months

Secondary outcomes

  1. Rate of covered stent-related complications

    Time frame: 1 month and 12 months

  2. Rate of technical success

    Time frame: up to 1 month

    successful positioning and deployment of the stents

  3. Primary patency rate

    Time frame: up to 60 months

  4. Secondary patency rate

    Time frame: up to 60 months

  5. Primary assisted patency rate

    Time frame: up to 60 months

  6. Change of Rutherford Classification

    Time frame: up to 60 months

  7. Change of ABI

    Time frame: up to 60 months

  8. Freedom from TLR

    Time frame: up to 60 months

  9. Freedom from MACE

    Time frame: up to 60 months

Study contacts

Contact information is provided by the study sponsor or research team.

Richard A Griesbach, Dr

CONTACT

[email protected]

+49 7471 9999 117

Sponsors and collaborators

Lead sponsor

Bentley InnoMed GmbH

Industry

Collaborators

  • KANDO Research

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Jun 8, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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