An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBentley InnoMed GmbH
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients with any contraindication according to the IFU
Previous stenting of the target vessel
Trial design
Treatments tested in this trial
- Stenting
Treatment groups
No treatment groups listed
Sponsors and collaborators
Bentley InnoMed GmbH
Lead sponsor
ID3 Medical
Collaborator
Source ClinicalTrials.gov