A prospective, multi-center, single-arm registry to evaluate the safety and efficacy of bare metal stent-assisted percutaneous transluminal angioplasty (PTA) in the treatment of superficial femoral and/or proximal popliteal artery (P1) lesions in patients with symptomatic peripheral artery disease
The purpose of this registry is to collect acute and follow-up (up to 12 months) safety and efficacy data on the ZENFlex™ Peripheral Stent System in the stent-assisted angioplasty treatment of patients with de novo or restenotic lesion(s) of the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA, P1 segment) when used according to IFU. Up to 100 subjects will be enrolled in this study at up to 5 sites in Germany. This study is a prospective, single-arm observational registry and does not include an active control arm. Therefore, no formal sample size calculation has been performed. All subjects will be evaluated at pre-discharge and during clinical follow-up visits 6 (182 ± 30 days) and 12 (365 ± 30 days) months post-procedure. Primary endpoints are patency rate after one year and composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.
Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin
Halle, Germany
RECRUITINGPatency rate
patency rate after one year defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or \> 0.15 when compared to post-procedure baseline) or restenosis with PVR \> 2.4 evaluated by Duplex Ultrasound
Time frame: 12 (365 ± 30 days) months
Procedure-related death
Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization。
Time frame: 12 (365 ± 30 days) months
TLR rate at 6 and 12months
The ratio of either repeat percutaneous or surgical revascularization for target lesions
Time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Sustained clinical improvement
an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.
Time frame: 12 (365 ± 30 days) months
WIQ at 6 and 12 months
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline
Time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention
Duplex-defined binary restenosis (PSVR \>2.4) of the target lesion post-procedure and at 6 and 12 months or at any time of re-intervention
Time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
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