NCT05883943进行中（未招募）不适用
First-in-Human Early Feasibility Clinical Evaluation of Safety, Efficacy and Utility of the Cook® Venous Valve System for Treatment of Chronic Venous Insufficiency
MED Institute Inc.3 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2023年4月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Freedom from major adverse events in the first 30 days
研究概览
简要总结
The purpose of this study is to learn about the safety, efficacy and utility of a medical device called the Cook® Venous Valve System. This device, percutaneously placed in the leg, is meant to help the blood flow correctly through the veins in the leg.
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
- •Limited inclusion criteria:
- •Documented symptomatic deep venous reflux in one limb
- •Deep venous reflux in the region of interest
排除标准
- •Age < 18 years
- •Cultural objections to porcine materials
- •Unwillingness or inability to comply with the follow-up
- •Unwillingness to provide study data for duration of study
- •Simultaneous participation in another device or drug study
- •Inability or refusal to give informed consent
- •Pregnant, or planning to become pregnant
- •Diagnosis of terminal illness with life expectancy less than 12 months
- •Complete symptom resolution with compliant compression therapy for three months
- •Untreated superficial venous disease
- •Medical interventions including any of the following: planned procedure of any leg, vascular intervention or major surgery within the last three months, implanted inferior vena cava filter
- •Medical history of any of the following: anticoagulation treatment for pulmonary embolism (within the last six months or ongoing), insulin dependent diabetes, chronic obstructive pulmonary disease, renal dysfunction requiring dialysis, leg amputation, bleeding diathesis, untreated or unresolved systemic infection or local infection, active malignancy except non-melanoma skin cancer, other acute or chronic medical condition that may cause noncompliance with the protocol or confound the study results, documented history of significant untreated stenosis within the arterial system
- •Positive coronavirus (COVID-19) test six days prior to implant procedure
- •Anatomical:
- •Inability to clearly visualize target implantation site
- •Tortuous target implantation site
- •Inadequate inflow and/or outflow to the target region
- •Procedural:
- •Inability to gain access to the access site vein
- •Untreated focal or diffuse stenosis
研究组 & 干预措施
Cook® Venous Valve System
Experimental
干预措施: Cook® Venous Valve System (Device)
结局指标
主要结局
Freedom from major adverse events in the first 30 days
时间窗: 30 days after enrollment
The primary safety endpoint is freedom from major adverse events (MAE) in the first 30 days, where MAE is defined as: death, clinically-driven reintervention, bleeding requiring transfusion, flow limiting dissection of the target vessel, or clinically significant deep vein thrombosis (DVT), pulmonary embolism, or device migration.
次要结局
- Freedom from MAE at three months, six months, and 12 months(Three months, six months, and 12 months after enrollment)
研究者
研究点 (3)
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