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NCT07010354
An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Conditions: Iliac Artery Stenosis, Iliac Artery Occlusion
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Bentley InnoMed GmbH
Location: AZORG Aalst
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 Criteria
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
Source: ClinicalTrials.gov (NCT07010354). StuddyBuddy aggregates publicly available trial information.