NCT02262949已完成不适用
A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System (REALITY2)
C. R. Bard8 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Stent performance
研究概览
简要总结
The purpose of this study is to assess the deliverability, clinical utility, safety and effectiveness of the 250 mm length size offering of the LifeStent® Vascular Stent.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
- •Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •The subject is ≥ 21 years old.
- •Female subjects of childbearing potential must have a negative urine or serum pregnancy test within seven days prior to index procedure. Female subjects who are surgically sterile or post-menopausal are exempt from having a pregnancy test.
- •The subject has lifestyle-limiting claudication or mild tissue loss defined as: Rutherford Category1 2-5 (moderate claudication to minor tissue loss).
- •The target lesion has angiographic evidence of stenosis or restenosis ≥50% or occlusion in the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.
- •The target vessel reference diameter is (by visual estimate) appropriate for treatment with available stent diameters of 6.0 and 7.0 mm.
- •There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
排除标准
- •The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
- •The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
- •The subject has a known contraindication (including allergic reaction) or sensitivity to antiplatelet/anticoagulant medication, nickel, titanium or tantalum.
- •The subject has a known sensitivity to contrast media that is not amenable to pretreatment with steroids or/and antihistamines.
- •The subject has a history of bleeding diatheses of coagulopathy.
- •The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
- •The subject has concomitant hepatic insufficiency,thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
- •The subject is receiving dialysis or immunosuppressive therapy.
- •The subject is participating in an investigational drug or another investigational device study.
- •The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy of less than two years.
- •The subject has extensive peripheral vascular disease, which,in the opinion of the investigator, precludes safe insertion of an introducer sheath.
- •The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- •The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
- •The subject is diagnosed with septicemia at the time of the study procedure.
- •Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device will not come into contact with the previously placed stent during treatment of the target lesion.
- •Lesions requiring the use of more than one investigational stent.
- •Bilateral disease in the native SFA and/or proximal popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days.
结局指标
主要结局
Stent performance
时间窗: intra operative
Stent deployment success; defined as a post-deployment stent length deviating \<10% from pre-deployment stent length (determined by an independent core lab). Placement accuracy based upon a rating scale completed by the investigator at time of index procedure.
Major Adverse Events (MAEs)
时间窗: 30 days
Occurence of death or target limb amputation or any target lesion revascularization/target vessel revascularization through 30 days post-index procedure. These events will be assessed by clinical evaluations.
次要结局
- Major Adverse Events (MAEs)(1 year)
- Target lesion/vessel revascularization(1 year)
- Target lesion patency(1 year)
研究者
研究点 (8)
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