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An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Sponsor: Bentley InnoMed GmbH
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.
Official title: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-08-08
Completion Date
2031-07-31
Last Updated
2025-09-19
Healthy Volunteers
No
Interventions
Stenting
Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
Locations (2)
AZ Sint Blasius
Dendermonde, Belgium
EOC - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland