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An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow | Clinical Trials | Clareo Health

RECRUITING

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

NCT07010354•Bentley InnoMed GmbH

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

AZ Sint Blasius

Dendermonde, Belgium

EOC - Ente Ospedaliero Cantonale

Lugano, Canton Ticino, Switzerland

Key Dates

Start Date

August 8, 2025

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2031

Last Updated

September 19, 2025

Enrollment

100

ESTIMATED participants

Conditions

Iliac Artery StenosisIliac Artery Occlusion

Interventions

Stenting

DEVICE

Contacts

Richard A Griesbach, Dr

CONTACT

+49 7471 9999 117 r.griesbach@bentley.global

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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