The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 29
- 主要终点
- The primary safety endpoint is the composite of the following Major Adverse Events:
研究概览
简要总结
A prospective, non blinded, single arm, multicenter study designed to assess the safety and effectiveness of the bioprosthetic, VenoValve, which is surgically implanted into the deep venous system for treatment of patients with deep venous valvular insufficiency ( C4b-C6 patients).
详细描述
The purpose of this study is to evaluate the VenoValve System (Hancock Jaffe Laboratories) in human patients. The VenoValve System is designed for treatment of chronic deep venous insufficiency. The VenoValve System enables improvement in chronic lower extremity venous reflux through an open surgical technique. The objective of this study is to assess the safety and effectiveness of the VenoValve System for the treatment of patients with deep venous valvular insufficiency and the associated complications.
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
盲法说明
Open Label
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
- •Failure of at least 3 months of standard care including compression therapy, and in C6 patients, wound care,
- •Axial deep reflux >1000 msec. at the level of the popliteal vein
- •Venous valvular incompetence from primary or secondary causes, e.g., post-thrombotic syndrome (PTS),
- •CEAP score: C4b, C4c, C5, or C6,
- •Diameter of native target vein ≥8 mm,
- •Age ≥18 years,
- •Ability to tolerate duplex ultrasound,
- •Ability to ambulate without assistance,
- •Able to attend scheduled post-treatment follow-up visits,
- •Willing and able to comply with all compulsory study procedures and provide informed consent prior to any study procedures being performed,
- •Negative COVID-19 test within 6 days of index procedure or record of full vaccination for COVID-19,
- •Female patients of childbearing potential must:
- •have negative pregnancy test at the screening visit or within 7 days of the index procedure, whichever is later,
- •not be breastfeeding or plan to breastfeed through completion of the study,
- •agree to use a medically acceptable method of preventing conception from the screening visit through completion of the study.
排除标准
- •Presence of superficial reflux,
- •Presence of untreated iliac/IVC obstruction greater than 50% in diameter reduction,
- •Previously documented hypercoagulable condition that cannot be adequately treated with anticoagulation,
- •Previous open surgical procedure in the ipsilateral deep venous system,
- •Venous stent in the ipsilateral femoral or popliteal vein,
- •Extensive infrainguinal obstruction of the venous system,
- •DVT or pulmonary embolism within 30 days of the planned procedure,
- •Active malignancy excepting non-melanoma skin cancer,
- •Arterial insufficiency with measured ABI <0.70
- •Lymphedema not due to venous disease,
- •Current or planned participation in another clinical trial within 30 days of treatment,
- •Minor venous procedures (e.g., superficial vein procedures or venous stenting) within 6 weeks of screening,
- •New York Heart Association Class III or greater,
- •Fibromyalgia,
- •Chronic narcotic usage,
- •Positive COVID-19 test within the last 3 months.
- •Other medical conditions or comorbidities which, in the opinion of the investigator, would interfere with study compliance,
- •Contraindication to anticoagulation,
- •Stainless steel sensitivity/ porcine tissue sensitivity,
- •Active superficial thrombophlebitis,
- •Thrombocytosis with platelet count > 1 million/microliter,
- •Unwilling or unable to comply with post-operative anticoagulation regimen.
研究组 & 干预措施
VenoValve
Subjects who receive VenoValve implant
干预措施: Hancock-Jaffe bioprosthetic venous valve (VenoValve®) (Device)
结局指标
主要结局
The primary safety endpoint is the composite of the following Major Adverse Events:
时间窗: 30 days
Death, Major Bleeding, Deep Wound Infection, Ipsilateral deep vein thrombosis, Pulmonary embolism in 75 patients. Rate of \>9% is expected
次要结局
- Major Adverse Event rates(3, 6, 12 months and annually thereafter through 5 years)