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Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07010354). StuddyBuddy aggregates publicly available trial information.