4-EVER Study - Physician-Initiated Trial Investigating the Safety of the Full 4F Endovascular Treatment Approach of Infra-Inguinal Arterial Stenotic Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
研究概览
简要总结
The objective of this clinical investigation is to evaluate puncture site complication rate as well as the short- and long-term (up to 24 months) outcome of treatment by means of Astron Pulsar / Astron Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions, using 4F compatible devices of BIOTRONIK and without the use of a closure device.
The hypothesis is that the primary patency at 12 months is non-inferior to the primary patency obtained in the Durability study (72.2%).
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
- •De novo, restenotic or reoccluded lesion located in the femoropopliteal arteries suitable for endovascular treatment
- •Patient presenting with a score from 2 to 4 according to the Rutherford classification
- •Patient is willing to comply with specified follow-up evaluations at the predefined time intervals times
- •Patient is >18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
- •Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
- •Patient is eligible for treatment with 4F compatible devices
- •Angiographic Inclusion Criteria:
- •The target lesions are located within the native superficial femoral artery: Distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis.
- •The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion
- •Length of the target lesion is =20 cm by visual estimation and can be covered with one stent
- •Target vessel diameter visually estimated is =4 mm and =6.5 mm
- •There is angiographic evidence of at least one-vessel-runoff to the foot
排除标准
- •Presence of another stent in the target vessel that was placed during a previous procedure
- •Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
- •Previous bypass surgery in the same limb
- •Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
- •Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
- •Perforation at the angioplasty site evidenced by extravasation of contrast medium
- •Patients with known hypersensitivity to nickel-titanium
- •Patients with uncorrected bleeding disorders
- •Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •Life expectancy of less than 12 months
- •Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis > 30%
- •Use of thrombectomy, atherectomy or laser devices during procedure
- •Any planned surgical intervention/procedure 30 days after the study procedure
- •Any patient considered to be hemodynamically unstable at onset of procedure
- •Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint
研究组 & 干预措施
4F portfolio products from Biotronik
The devices under investigation are the 4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18 and Cruiser-18.
干预措施: 4F portfolio products from Biotronik (Device)
结局指标
主要结局
Primary patency at 12 months as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) <2.5 in the target vessel with no reintervention
时间窗: 12 months
Primary patency at 12 months, defined as freedom from \>50% restenosis
次要结局
- Primary patency(6- & 24-month follow-up)
- Clinical success(6-, 12- & 24-month follow-up)
- Stent fracture rate at 12- & 24-month follow-up(12- & 24-month follow-up)
- Technical success(1 day post-procedure)
- Puncture site complications(10 days)