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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Jul 31, 2026 to Dec 31, 2027
    • Study sites: 2 to 5
    • Study completion date: Jul 31, 2031 to Dec 31, 2031
    • Collaborator revised
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Jul 2026 to Jul 31, 2026
    • Study completion date: Jul 2031 to Jul 31, 2031
    • Start date changed from estimate of Jul 2025 to Aug 8, 2025
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 1 word
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07010354
Lead Sponsor Bentley InnoMed GmbH
Collaborators: KANDO Research
Conditions
(from sponsor)		 Iliac Artery Stenosis, Iliac Artery Occlusion
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov