NCT03775226终止不适用
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients With Femoro-Popliteal Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Medinol Ltd.
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Primary patency of the target lesion at 6 months.
研究概览
简要总结
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease
详细描述
Device Overview:
The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.
Objectives:
- To assess the safety and feasibility of delivery and implantation of ChampioNIR® SFA Stent.
- To assess the early and long term ability of the stent to maintain vessel patency.
- To assess the long term safety of the ChampioNIR® SFA Stent.
This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation. All enrolled patients will be followed up at 30 days and up to 36 months. The follow-up visits will include patency evaluation by duplex ultrasound.
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
- •Age ≥ 18 years and of age of legal consent.
- •Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) <0.90/0.
- •A single superficial femoral artery lesion with >50% stenosis or total occlusion.
- •Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
- •Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.
- •Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
- •Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (<50% stenosis) to the ankle or foot.
- •The target lesion(s) can be successfully crossed with a guide wire and dilated.
- •The subject is eligible for standard surgical repair, if necessary.
- •Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.
排除标准
- •Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- •Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
- •Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- •Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined >50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion.
- •Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
- •Presence of an ipsilateral arterial artificial graft.
- •Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
- •Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- •Required stent placement (in the target or any other lesion) via a retrograde approach.
- •Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
- •Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
- •Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
- •Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
- •Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
- •Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
- •Subject has tissue loss, defined as Rutherford-Becker classification category 5 or
- •Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
- •Stroke within the previous 90 days.
- •Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.
- •Receiving dialysis or immunosuppressant therapy within the previous 30 days.
- •Known or suspected active infection at the time of the procedure.
- •History of neutropenia, coagulopathy, or thrombocytopenia.
- •Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
- •Platelet count <80,000/μL
- •International normalized ratio (INR) > 1.5
- •GFR <30 ml/min by Cockroft-Gault.
- •Subject requires general anesthesia for the procedure.
- •Subject has a co-morbid illness that may result in a life expectancy of less than 1 year
- •Planned use of a drug coated balloon (DCB) during the index procedure.
- •Pregnant women or women of child bearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
- •Subject is participating in any investigational study that has not yet reached its primary endpoint.
结局指标
主要结局
Primary patency of the target lesion at 6 months.
时间窗: 6 months
Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) \>2.4)
Composite rate of freedom
时间窗: 30 Day
from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.
次要结局
- Primary patency defined by Duplex US(30 days and 12 months.)
- Combined rate 30 day(12 months)
- Acute procedural success(index procedure)
- Acute technical success(index procedure)
- Secondary Patency absence of restenosis which is defined as Duplex US(30 days 6, 12, 24 and 36 months)
- Acute device success(index procedure)
- Freedom from all-cause death, index limb amputation above the ankle and TVR.(30 days)
- Amputation (above the ankle)(30 days, 6, 12, 24 and 36 months)
- Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature(30 days, 6, 12, 24 and 36 months)
- All-cause death(30 days, 6, 12, 24 and 36 months)
- The following Major Adverse Limb Events will be evaluated either by angiography or clinical examination. These will be assessed by reviewing angiograms by the core-lab and clinical events will be adjudicated by a CEC(30 days, 6, 12, 24 and 36 months)
- Rutherford classification(30 days 6, 12, 24 and 36 months)
- walking impairment questionnaire(30 days 6, 12, 24 and 36 months)
- Target Vessel Revascularization(30 days, 6, 12, 24 and 36 months)
- Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follow(30 days 6, 12, 24 and 36 months)
- resting ankle-brachial index(30 days 6, 12, 24 and 36 months)
- six minute walk test(30 days 6, 12, 24 and 36 months)
研究者
研究点 (3)
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