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

Bentley InnoMed

Status: Enrolling

Conditions: Iliac Artery Occlusion; Iliac Artery Stenosis

Treatments: Device: Stenting

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07010354

PM15-01 BeFlow

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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