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RecruitingNCT07010354

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

An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System

Status
Recruiting
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Bentley InnoMed GmbH · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2025-08-08
Primary completion
2026-07-31
Completion
2031-07-31
First posted
2025-06-08
Last updated
2025-09-19

Locations

2 sites across 2 countries: Belgium, Switzerland

Source: ClinicalTrials.gov record NCT07010354. Inclusion in this directory is not an endorsement.

An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow (NCT07010354) · Clinical Trials Directory