An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBentley InnoMed GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with any contraindication according to the IFU
Previous stenting of the target vessel
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Stenting
DeviceEndovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary patency rate
Time frame
12 monthsSecondary outcomes
1
Rate of covered stent-related complications
Time frame
1 month and 12 months2
Rate of technical success
successful positioning and deployment of the stents
Time frame
up to 1 month3
Primary patency rate
Time frame
up to 60 months4
Secondary patency rate
Time frame
up to 60 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bentley InnoMed GmbH
Lead sponsor
KANDO Research
Collaborator
Source ClinicalTrials.gov