BeFlow safety, performance, and benefit for iliac artery stenting
An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System
This project will try the BeFlow stent in adults with narrowed or blocked iliac arteries to see if it is safe and improves blood flow.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bentley InnoMed GmbH Industry-sponsored |
| Locations | 2 sites (Dendermonde and 1 other locations) |
| Trial ID | NCT07010354 on ClinicalTrials.gov |
What this trial studies
This is an international, observational, multicenter registry that will follow adults treated with the BeFlow stent for iliac artery stenosis or occlusion. The study will record technical success of implantation, device performance, clinical outcomes, and any unexpected adverse events in real-world practice following the device's instructions for use. Enrolled patients who meet inclusion criteria will receive standard-of-care iliac stenting and be followed at predefined visits to collect safety and effectiveness data. No randomization or experimental procedures beyond the approved stenting procedure are planned.
Who should consider this trial
Good fit: Adults aged 18 or older with an indication for permanent intraluminal stenting of the iliac arteries per the device instructions for use, who can provide informed consent and have not had prior stenting of the target vessel.
Not a fit: Patients with contraindications listed in the device instructions for use or with a prior stent in the target vessel are not likely to benefit from participation.
Why it matters
Potential benefit: If successful, the BeFlow stent could offer a safe and effective option to restore blood flow in patients with iliac artery narrowing or blockage.
How similar studies have performed: Endovascular iliac stenting with modern stents has previously shown symptom relief and improved vessel patency, but the BeFlow device itself is being specifically monitored in this observational registry.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dendermonde and 1 other locations
- AZ Sint Blasius — Dendermonde, Belgium (Recruiting)
- EOC - Ente Ospedaliero Cantonale — Lugano, Canton Ticino, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Richard A Griesbach, Dr
- Email: r.griesbach@bentley.global
- Phone: +49 7471 9999 117
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.