Clinical Investigation of the Rex Medical -Closer™ Vascular Closure System -Reduced Time to Ambulation Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to Ambulation
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the Rex Medical Closer™ Vascular Closure System to close the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures with early ambulation and discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Subject is > 18 years of age.
- •Subject is able to undergo diagnostic angiography procedure and is found suitable to receive such a device at the femoral arterial puncture site in order to reduce time to hemostasis.
- •Subject or his/her legal guardian understands the nature of the procedure, and provides written informed consent prior to the procedure.
- •Subject is available and willing to participate in follow-up through 30 days post femoral closure.
排除标准
- •Subject with known allergies to polylactic acid (PLA), polyglycolic acid (PGA) or polydioxanone (PDO) polymers
- •Subject with severe acute non-cardiac systemic disease
- •Subject with evidence of systemic infection
- •Subject where bacterial contamination of the procedural sheath or surrounding tissues may have occurred as this may increase risk of infection
- •Subject with coagulopathy (bleeding disorders, including thrombocytopenia, hemophilia, etc.)
- •Subject taking thrombolytic medication which reduces fibrinogen to less than 100 mg/dl
- •Subject who has had a previous arterial access in the femoral artery on the treatment side with an existing hematoma >5 cm in diameter
- •Subject who is unable to ambulate at baseline
- •Subject who has had another closure device used in the treatment side within the previous 90 days
- •Subject who requires re-entry of the treatment side planned within the next 90 days post-procedure
- •Subject has a history of surgical repair on the treatment side
- •Subject has planned surgeries for any reason within 90 days post- procedure
- •Subject is pregnant or is lactating (non-pregnancy must be confirmed by testing)
- •Has a history of a psychiatric condition, substance abuse or alcohol abuse that, in the opinion of the investigator, will potentially interfere with his or her participation
- •Subject has been previously enrolled in the Rex Closer™ study
- •Subject who is currently or within the previous 4 weeks been enrolled in another investigational device or drug trial
- •Subject is incarcerated at the time of enrollment
- •Subject where the procedural sheath has been placed through the superficial femoral artery and into the profundafemoris
- •Subject where the procedure puncture site is at or distal to the bifurcation of the superficial femoral profundafemoris artery, as this may result in 1) the intravascular sealing patch catching on the bifurcation or being positioned incorrectly, and/or 2) intravascular deployment of the device into the vessel (These events may reduce blood flow through the vessel leading to symptoms of distal arterial insufficiency.)
- •Subject's procedure was accessed through a vascular graft
- •Subjects with uncontrolled hypertension (> 230 mm Hg systolic)
- •Subjects with small femoral artery size (Less than 5 mm in diameter)
- •Subjects with stenosis > 50% at the vicinity of the femoral arterial puncture site
- •Subjects with anomalous branches or vessel abnormalities present in the vicinity of the femoral arterial puncture site
研究组 & 干预措施
Single Arm
This is a single arm, prospective study to collect data on the safety and effectiveness of the Rex Medical Closer™ Vascular Closure System. Only subjects who are scheduled to undergo an interventional diagnostic procedure that requires closure of the femoral access site are eligible for study participation.
干预措施: Rex Medical Closer™ Vascular Closure System (Device)
结局指标
主要结局
Time to Ambulation
时间窗: Day 0
Time to Ambulation - in minutes, defined as the time from when hemostasis is achieved to the time when ambulation is achieved (patient standing and walking at least 6.1 meters \[20 feet\] without re-bleeding).
Frequency of Major Adverse Events through 30 days
时间窗: 30 days
The primary safety endpoint is the frequency of Major Adverse Events through 30 days, defined as one of the following events related to the use of the investigational device: a hematoma requiring a transfusion, a device embolization, false aneurysm requiring intervention or a retroperitoneal bleed.
次要结局
- Placement Technical Success(Day 0)
- Clinical Success(Day 0)
- Time to Hemostasis(Day 0)