The objective of this study is to evaluate the immediate and long-term (up to 12 months) safety and effectiveness of primary stenting with the Protégé Everflex+ stent system for the treatment of superficial femoral artery (SFA) lesions (without involvement of the popliteal artery) between 40 mm and 180 mm in length.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
* pre-dilation of the study lesion is mandatory * stent placement with 1 Protégé Everflex+ stent * only 1 stent is allowed within the study protocol * post-dilation may be performed but is not mandatory
Imelda Hospital
Bonheiden, Antwerp, Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium
A.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium
Major Adverse Event rate
The primary safety endpoint of the study is the Major Adverse Event (MAE) rate at 30 days. MAE is defined as: clinically-driven target lesion revascularization, amputation of treated limb or all-cause mortality through 30 days post procedure.
Time frame: 30 days post-procedure
Primary stent patency
The primary effectiveness endpoint of the study is primary stent patency at 12 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
Time frame: 12 months post-procedure
Technical success
Technical success, defined as the ability to cross and stent the lesion, after predilation, and with or without additional post-dilation, and achieve residual angiographic stenosis no greater than 30%
Time frame: 1 day post-procedure
Primary stent patency at 1 and 6 months
Primary patency at 1, 6 months. Primary patency is defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up.
Time frame: 1 and 6 months post-procedure
Primary assisted patency
Primary assisted patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Time frame: 1, 6 and 12 months post-procedure
Secondary patency
Secondary patency rate at 1, 6, 12-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
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Time frame: 1, 6 and 12 months post-procedure
Target lesion revascularization
Target lesion revascularization (TLR) is defined as a repeat intervention, within the study follow-up period of 12 months, to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
Time frame: 12 months post-procedure
limb-salvage
Limb-salvage rate at all follow-up visits for the subgroup of patients with critical limb ischemia (Rutherford category 4), defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot)
Time frame: 12-months post-procedure
Clinical success
Clinical success at follow-up, defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification
Time frame: 1, 6 and 12 months post-procedure
Serious adverse events
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.
Time frame: 12-months post-procedure