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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-08

Study Completion Date

2031-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Iliac Artery Stenosis Iliac Artery Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Stenting

Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent

Intervention Type DEVICE

Eligibility Criteria

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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