Actively Recruiting
An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Led by Bentley InnoMed GmbH · Updated on 2025-09-19
100
Participants Needed
2
Research Sites
311 weeks
Total Duration
On this page
Sponsors
B
Bentley InnoMed GmbH
Lead Sponsor
I
ID3 Medical
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6518 years of age at the time of consent
You will not qualify if you...
- Patients with any contraindication according to the IFU
- Previous stenting of the target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
AZ Sint Blasius
Dendermonde, Belgium, 9200
Actively Recruiting
2
EOC - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland, 6900
Not Yet Recruiting
Research Team
R
Richard A Griesbach, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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