Iliac Artery Stenosis, Iliac Artery Occlusion
Conditions
Brief 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.
Interventions
DEVICEStenting
Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
Sponsors
ID3 Medical
Bentley InnoMed GmbH
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rate | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of technical success | up to 1 month | successful positioning and deployment of the stents |
| Primary patency rate | up to 60 months | — |
| Secondary patency rate | up to 60 months | — |
| Primary assisted patency rate | up to 60 months | — |
| Rate of covered stent-related complications | 1 month and 12 months | — |
| Change of ABI | up to 60 months | — |
| Freedom from TLR | up to 60 months | — |
| Freedom from MACE | up to 60 months | — |
| Change of Rutherford Classification | up to 60 months | — |
Countries
Belgium, Switzerland
Contacts
Primary ContactRichard A Griesbach, Dr
Outcome results
None listed