ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patency rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is ≥ 18 years old at the time of consent.
- •Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.
- •Rutherford Classification Category 2-
- •Subjects with Rutherford Class 2 have gone through a conservative therapy without success.
- •De novo stenotic, restenotic or occlusive lesion(s) located in the superficial femoral artery and/or proximal popliteal artery (P1 segment) suitable for stenting after PTA.
- •Lesion location starts distal to CFA bifurcation (below origin of deep femoral artery) and should not extend beyond the P1 segment of the popliteal artery.
- •Lesion(s) is/are located at least 2 cm from any stent if target limb was already previously stented.
- •>70 % diameter stenosis or occlusion by visual angiographic estimate.
- •Patent inflow (treatment of inflow is allowed before treatment of the target lesion if successful).
- •Patent ipsilateral popliteal artery (P2 and P3 segments) and at least 1 patent infrapopliteal artery in continuity to ankle.
- •Target reference vessel diameter ≥ 4 - ≤ 7.0 mm.
排除标准
- •Patients will be excluded from the registry if any of the following criteria is met:
- •Target Lesion previously tested with a stent or surgery.
- •Rutherford Classification Category 0, 1, 5 or
- •Inability to tolerate antithrombotic or antiplatelet therapies.
- •Known allergy or contraindication to contrast medium that, in the opinion of the investigator, can't be adequately pre-medicated.
- •Non-dilatable severely calcified lesion.
- •Known hypersensitivity to nitinol and/or its components (e.g. nickel, titanium).
- •Acute or subacute thrombus in the target lesion.
- •Documented life expectancy < 13 months
- •Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding.
- •Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
- •Myocardial infarction or stroke within 90 days prior to index procedure.
- •Hypercoagulable state.
- •Patient is currently enrolled in any other clinical investigational trial(s).
- •Use of alternative therapy in target lesion during index procedure, e.g. atherectomy, lysis therapy, laser therapy, DES, re-entry-devices, cutting / scoring balloon
研究组 & 干预措施
ZENFLEX stent Group
subjects applying ZENFLEX peripheral stent system
干预措施: ZENFLEX peripheral stent system (Device)
结局指标
主要结局
Patency rate
时间窗: 12 (365 ± 30 days) months
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
Procedure-related death
时间窗: 12 (365 ± 30 days) months
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。
次要结局
- TLR rate at 6 and 12months(6 (182 ± 30 days) and 12 (365 ± 30 days) months)
- Sustained clinical improvement(12 (365 ± 30 days) months)
- Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention(6 (182 ± 30 days) and 12 (365 ± 30 days) months)
- WIQ at 6 and 12 months(6 (182 ± 30 days) and 12 (365 ± 30 days) months)