NCT02462876已完成不适用
Post-market Study: Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm
W.L.Gore & Associates1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Subjects With a Safety-related Event at 12 Months
研究概览
简要总结
This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Inclusion to the study requires the patient:
- •Received a GORE® VIABAHN® Endoprosthesis to treat a popliteal artery aneurysm
- •Had a symptomatic aneurysm or asymptomatic aneurysm (≥ 2 cm diameter) of the popliteal artery, or the presence of mural thrombus (< 2 cm) in the popliteal artery;
- •Was 18 years of age or older at the time of the treatment;
- •Had an elective popliteal artery aneurysm procedure;
- •Has provided Informed Consent, personally or through lawful representation as determined by applicable local regulations and state law
排除标准
- •Prior to or at the time of implant the patient is / has:
- •Bilateral popliteal artery aneurysms with initial treatment on the same day;
- •Thrombotic occlusion of the popliteal artery or PAA;
- •Marfan syndrome or Ehlers-Danlos syndrome;
- •Unable to tolerate antiplatelet therapy;
- •Thrombophilia requiring long term anticoagulation;
- •Known allergies to the GORE® VIABAHN® Endoprosthesis components;
- •Enrolled in another investigational drug or medical device trial where participation may have affected the outcome or treatment of the subject in the popliteal artery aneurysm study with the GORE® VIABAHN® Endoprosthesis or had previous surgery for the popliteal artery aneurysm in the study limb.
结局指标
主要结局
Number of Subjects With a Safety-related Event at 12 Months
时间窗: 12 months
Safety-related events are defined as serious adverse events and adverse events related to the study procedure or the study device through 12 months
Number of Subjects With Primary Patency at 12 Months
时间窗: 12 months
Primary Patency is defined as blood flow without occlusion maintained through the device after implant without an intervention evaluated at 12 months.
次要结局
- Probability of Freedom From Repeat Intervention(12, 24, and 36 months)
- Length of Hospital Stay(During hospitalization, approximately 1-2 days)
- Probability of Primary Assisted Patency(12, 24, and 36 months)
- Probability of Secondary Patency(12, 24, and 36 months)
- Number of Subjects With Technical Success(Post-procedure at day 30)
- Number of Subject With a Safety-related Event at 24 and 36 Months(24 and 36 months)
- Length of Procedure(During procedure, approximately 120 minutes)
- Probability of Primary Patency(12, 24, and 36 months)
- Probability of Freedom From Limb Loss(12, 24, and 36 months)
研究者
研究点 (1)
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