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
Bentley InnoMed GmbH
100 participants
Aug 8, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria2
- Patients with any contraindication according to the IFU
- Previous stenting of the target vessel
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Interventions
Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07010354