Iliac Artery StenosisNCT07010354
An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
An observational study of Iliac Artery Stenosis and Iliac Artery Occlusion, run by Bentley InnoMed GmbH at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Artery Stenosis, Iliac Artery Occlusion
- What is being tested?
- Stenting
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 8 Aug 2025to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18 years of age) suffering from stenotic lesions in the iliac arteries caused by arteriosclerosis or other pathologies that may be treated by stenting.
Who may be able to join
- 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
Who cannot join
- Patients with any contraindication according to the IFU
- Previous stenting of the target vessel
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Belgium4 sites, 4 recruiting
- Recruiting
AZORG
Aalst, 9300
Lieven Maene, Dr., +32 53 72 41 11, klinischestudies.secretariaat@azorg.be
- Recruiting
AZ Sint Blasius
Dendermonde, 9200
Koen Deloose, MD, + 32 52 25 20 11, koen.deloose@vascular.be
- Recruiting
Ziekenhuis Oost-Limburg AV
Genk, 3600
Wouter Lansink, Dr., +32 89 80 80 80, wouter.lansink@zol.be
- Recruiting
CHU de Liège
Liège, 4000
Arnaud Kerzmann, Dr., +32 4 323 0000, akerzmann@chuliege.be
Switzerland1 site, 1 recruiting
- Recruiting
EOC - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, 6900
Maria Antonella Ruffino, MD, EBIR, FCIRSE, +41 91 811611 1, MariaAntonella.Ruffino@eoc.ch
About this study
Official title: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System
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
- Iliac Artery Stenosis, Iliac Artery Occlusion
- Being tested
- Stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentingDevice
Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Measured: 12 months
Secondary outcomes (9)
Rate of covered stent-related complications
Measured: 1 month and 12 months
Rate of technical success
successful positioning and deployment of the stents
Measured: up to 1 month
Primary patency rate
Measured: up to 60 months
Secondary patency rate
Measured: up to 60 months
Primary assisted patency rate
Measured: up to 60 months
Change of Rutherford Classification
Measured: up to 60 months
Change of ABI
Measured: up to 60 months
Freedom from TLR
Measured: up to 60 months
Freedom from MACE
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start8 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bentley InnoMed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KANDO Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010354
- Sponsor's protocol ID
- PM15-01 BeFlow
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of the BeFlow Iliac Covered Stent System
- ClinicalTrials.gov ID
- NCT07010354
- Acronym / sponsor ID
- PM15-01 BeFlow
- Conditions
- Iliac Artery Stenosis, Iliac Artery Occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bentley InnoMed GmbHIndustry (pharma, biotech, devices)
- Collaborators
- KANDO Research
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18 years of age) suffering from stenotic lesions in the iliac arteries caused by arteriosclerosis or other pathologies that may be treated by stenting.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with any contraindication according to the IFU
- Previous stenting of the target vessel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StentingEndovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent | Device | – |
Primary outcome
Primary patency rate
Time frame: 12 months
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Artery Stenosis and Iliac Artery Occlusion, run by Bentley InnoMed GmbH at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard A Griesbach, Dr (+49 7471 9999 117, r.griesbach@bentley.global), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.