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 Type
OBSERVATIONAL
Enrollment
100
Endovascular treatment of stenosed or occluded iliac arteries: Permanent intraluminal placement of a covered stent
AZ Sint Blasius
Dendermonde, Belgium
RECRUITINGEOC - Ente Ospedaliero Cantonale
Lugano, Canton Ticino, Switzerland
NOT_YET_RECRUITINGPrimary patency rate
Time frame: 12 months
Rate of covered stent-related complications
Time frame: 1 month and 12 months
Rate of technical success
successful positioning and deployment of the stents
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
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