临床试验/NCT01663051

NCT01663051已完成不适用

Evaluation of the Zilver® Vena™ Venous Stent

Cook Group Incorporated5 个研究点分布在 5 个国家目标入组 35 人开始时间: 2012年11月最近更新: 2016年11月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cook Group Incorporated
入组人数: 35
试验地点: 5
主要终点: Major Adverse Events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This prospective, non-randomized, multi-center study is intended to evaluate the Zilver® Vena™ stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

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

•Symptomatic venous outflow obstruction in up to two iliofemoral venous segments (one in each limb), demonstrated by:
•CEAP 'C' ≥ 3, or
•VCSS pain score ≥ 2

排除标准

•< 18 years of age
•Pregnant or planning to become pregnant in the next 12 months
•Planned surgical or interventional procedures (except thrombolysis and thrombectomy in preparation for the procedure or vena cava filter placement prior to stent implantation in patients at high risk for pulmonary embolism) within 30 days prior to or after the study procedure.
•Lesions with intended treatment lengths extending into the inferior vena cava or below the level of the lesser trochanter
•Previous stenting of the target vessel
•Iliofemoral venous segment unsuitable for treatment with available sizes of study devices

结局指标

主要结局

Major Adverse Events

时间窗: 1 month

Patency

时间窗: 12 months

Assessed via ultrasound

次要结局

未报告次要终点

研究者

发起方

Cook Group Incorporated

申办方类型

Industry

责任方

Sponsor

研究点 (5)

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