Prospective Investigation of The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety endpoint of subjects free from specified adverse events
研究概览
简要总结
This is a prospective, single-center, non-randomized phase 2, first-in-iliac artery study, to evaluate the safety and effectiveness of the WRAPSODY Stent Graft for the treatment of peripheral arterial occlusive disease in symptomatic subjects with de novo or restenotic lesions in the common iliac artery (CIA) and/or external iliac artery (EIA), including lesions at the aortic bifurcation.
详细描述
Approximately 30 subjects will be enrolled. Post study procedure subjects will have planned follow-up visits at 4 weeks, 24, 36 and 52 weeks, and unscheduled visits as medically necessary,
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure. The primary clinical effectiveness endpoint is the proportion of subjects with a composite improvement of at least 1 Rutherford category and patency as evaluated by duplex ultrasound at 4 weeks after index procedure.
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
- •Subject has signed informed consent
- •Subject is ≥ 21 years of age
- •Subject is able and willing to comply with study requirements
- •Male, infertile female, or female practicing contraception and a negative pregnancy test within 7 days prior to the study procedure
- •Symptomatic claudication or rest pain without tissue loss, Rutherford category 2-4
- •Angiographic evidence of de novo or restenotic target lesion(s) in native vessels in the common and/or external iliac artery(ies) (multiple stenoses may exist within the target lesion)
- •Total lesion(s) length is ≤ 110mm
- •Target lesion(s) is at least 3 cm from an existing stent or stent graft
- •At least 1 stenosis in the target vessel has ≥ 50% stenosis
- •Target vessel diameter is between 4.6 and 14.4mm at angiographic screening for device placement
- •Adequate ipsilateral blood flow, including at least 1 patent (<50% stenotic) superficial femoral or profundal femoral artery
- •Full expansion of an appropriately sized (in the investigator's opinion) standard angioplasty balloon has been achieved during primary angioplasty at the target lesion prior to enrollment
排除标准
- •Subject has undergone an intervention (surgical or percutaneous) in the target limb(s) <30 days from the date of the index study procedure
- •Subject has a surgical or percutaneous procedure in the target limb(s) planned within 30 days following the index study procedure
- •Previous or planned bypass surgery in the target limb(s)
- •Coronary intervention within 30 days prior to enrollment or planned within 12 months after index study procedure
- •Subject has had a stroke within 90 days prior to the index study procedure
- •Subject has had a transient ischemic attack within 30 days prior to the index study procedure
- •Uncorrectable coagulation disorder
- •Subject cannot receive heparin, dual antiplatelet treatment, or anticoagulant(s) appropriate in the opinion of the investigator
- •Condition unrelated to study anticipated to require indefinite anticoagulation
- •Evidence of blood borne infection
- •Hypersensitivity to nickel titanium alloy
- •Allergy to radiographic contrast material which cannot be adequately premedicated
- •Serum creatinine >2.5mg/dL
- •The subject is enrolled in another investigational study
- •Life expectancy is ≤ 12 months
- •Active malignancy other than non-melanomatous skin cancer
- •Stenosis/restenosis is located within a previously placed stent or stent graft
- •Angiographic evidence of thrombus within or adjacent to the target lesion(s)
- •Aneurysmal dilation proximal or distal to the target lesion(s) that could interfere with placement of the study device
- •Abdominal aortic artery stent, if it could interfere with placement of the study device
- •Target lesion(s) are located such that the stent graft would prevent blood flow to the internal iliac artery, if patent
- •Lesions requiring atherectomy or ablation to facilitate stent graft delivery
- •Any other condition deemed exclusionary in the opinion of the investigator for documented reasons relating to the health and/or welfare of the subject
结局指标
主要结局
Safety endpoint of subjects free from specified adverse events
时间窗: 4 weeks after placement of WRAPSODY stent graft
The primary study safety endpoint is the proportion of subjects free from a composite of device- or procedure-related death, myocardial infarction, or amputation above the metatarsals in the treated leg resulting from a vascular event, or device- or procedure-related serious adverse events within 4 weeks of the index procedure.
Effectiveness endpoint of subjects with improvement of Rutherford Category
时间窗: 4 weeks after placement of WRAPSODY stent graft
The primary clinical effectiveness endpoint is the proportion of subjects with improvement of at least 1 Rutherford category within 4 weeks of the index procedure. Composite with Outcome 3.
Effectiveness endpoint of subjects with patency
时间窗: 4 weeks after placement of WRAPSODY stent graft
The primary clinical effectiveness endpoint is the proportion of subjects with patency as evaluated by duplex ultrasound at 4 weeks after index procedure. Composite with Outcome 2.
次要结局
未报告次要终点