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Recruiting NCT07010354

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

— Observational Iliac Artery Stenosis Iliac Artery Occlusion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stenting.
Who it may be relevant to
Registry conditions: Iliac Artery Stenosis, Iliac Artery Occlusion. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Primary patency rate [Time frame: 12 months]
Secondary outcome measures (9)
  • Rate of covered stent-related complications [Time frame: 1 month and 12 months]
  • Rate of technical success [Time frame: up to 1 month]
  • Primary patency rate [Time frame: up to 60 months]
  • Secondary patency rate [Time frame: up to 60 months]
  • Primary assisted patency rate [Time frame: up to 60 months]
  • Change of Rutherford Classification [Time frame: up to 60 months]
  • Change of ABI [Time frame: up to 60 months]
  • Freedom from TLR [Time frame: up to 60 months]
  • Freedom from MACE [Time frame: up to 60 months]

Eligibility criteria

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

Exclusion criteria

  • Patients with any contraindication according to the IFU
  • Previous stenting of the target vessel

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 4 centers
  • AZORG — Aalst
  • AZ Sint Blasius — Dendermonde
  • Ziekenhuis Oost-Limburg AV — Genk
  • CHU de Liège — Liège
Switzerland · 1 center
  • EOC - Ente Ospedaliero Cantonale — Lugano

Identifiers

NCT: NCT07010354 · PM15-01 BeFlow

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗