NCT01961167已完成不适用
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries
W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2013年12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
- 27
- 试验地点
- 1
- 主要终点
- Composite of Major Adverse Events (MAEs)
研究概览
简要总结
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.
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 at least 18 years old;
- •Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
- •Patient or legal representative is willing to give written informed consent;
- •Patient is capable of complying with protocol requirements, including all follow-up visits;
- •Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
- •Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery
排除标准
- •Patient has a life expectancy of less than 1 year;
- •Patient has a known allergy to stent graft components, including stainless steel or heparin;
- •Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol;
- •Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation
- •Patient has had vascular access / catheterization in the lower extremity within 30 days of study enrollment;
- •Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the study procedure;
- •Patient is currently participating in this or another investigative clinical study.
- •Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
- •Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
- •Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
- •Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent
结局指标
主要结局
Composite of Major Adverse Events (MAEs)
时间窗: 30 days
Percentage of study subjects experiencing a major adverse event (MAE) defined as: * Device- or procedure-related death within 30 days of the index procedure; and * Myocardial Infarction (MI) occurring within 30 days of the index procedure; and * Amputation above the metatarsals in the treated leg, resulting from a vascular event, occurring within 30 days of the index procedure.
次要结局
- Change in Functional Status - EQ5D - Usual Activities(6 Months)
- Freedom From Target Lesion(s) Revascularization (TLR)(6 Months)
- Number of Participants With Change in Rutherford Category(6 Months)
- Secondary Patency(6 Months)
- Change in Functional Status - EQ5D - Self Care(6 Months)
- Acute Procedural Success(Discharge)
- Thirty-day Clinical Success(30 Days)
- Primary Patency(6 Months)
- Freedom From Target Vessel Revascularization (TVR)(6 Months)
- Change in Functional Status - EQ5D- Mobility(6 Months)
- Number of Participants With Improvement in Differential Diagnoses at 180 Days - Walking Impairment Questionnaire (WIQ)(6 Months)
- Primary Assisted Patency(6 Months)
- Number of Participants With a Change in Rutherford Category(30 Days)
- Freedom From Major Adverse Events (MAEs)(6 months)
- Change in Ankle Brachial Index (ABI)(6 Months)
- Change in Functional Status - EQ5D - Pain/Discomfort(6 Months)
- Number of Participants With Improvement in Differential Diagnoses at 30 Days - Walking Impairment Questionnaire (WIQ)(30 day)
- Change in Functional Status - EQ5D - Anxiety/Depression(6 Months)
- Change in Functional Status - EQ5D- Own Health State(6 Months)
研究者
研究点 (1)
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