Atherosclerosis of Femoral Artery Clinical Trial
Official title:
ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
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. ;
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