This study will assess the results up to 12 months with the Protégé EverFlex stent (ev3) in patients presenting with a narrowing or blocking at the level of the knee artery, which leads to a limited walking distance, rest pain or non-healing ulcers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
implantation of one Protégé EverFlex stent
Imeldaziekenhuis
Bonheiden, Antwerp, Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium
Heilig-Hart Ziekenhuis
Tienen, Flemish Brabant, Belgium
primary patency
primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without TLR within 12 months
Time frame: 12 months post-procedure
Technical success
Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex imaging
Time frame: 1 day post-procedure
Primary patency rate at 6-, 12-month follow-up.
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent.
Time frame: 6-, 12-month follow-up
Clinical success
Clinical success at follow-up is defined as an improvement of Rutherford classification at 6-, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: 6-, 12-month follow-up
tent fracture rate at 12-month follow-up
Determined according the following classification on x-ray: Class 0 (no strut factures); Class I (single tine fracture); Class II (multiple tine factures); Class III (Stent fracture(s) with preserved alignment of the components); Class IV (Stent fracture(s) with mal-alignment of the components); Class V (Stent fracture(s) in a trans-axial spiral configuration)
Time frame: 12-month follow-up
Serious adverse events
Defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
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Time frame: 1 year