NCT02694549终止不适用
Prospective, Single Arm Study to Assess the Performance and Safety of CaveoVasc System for Femoral Vascular Access and Closure Device
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Primary Performance Endpoint
研究概览
简要总结
The purpose of this study is to assess the performance and safety of the CaveoVasc® System for femoral vascular access and for prevention of bleeding from the femoral artery puncture site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Patients eligible for a non-emergent diagnostic or interventional catheterization via a femoral sheath of less or equal 6Fr
- •In the investigator's opinion, the patient is suitable for the CaveoVasc® System , conventional hemostasis techniques and participation in an investigational trial.
- •Understand and sign the study specific written informed consent form.
排除标准
- •Patients with significant anemia (hemoglobin <10g/DL, Hct<30).
- •Patients with a baseline INR > 1.5
- •Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance < 30 mL/min, platelets count < 100,000 mm3), patients with chronic use of vitamin K antagonists, direct thrombin inhibitors or oral factor Xa antagonists
- •Severe concomitant disease with life expectancy below 12 months
- •Uncontrolled systemic hypertension
- •Patients who are immunocompromised.
- •Patients who need a puncture needle longer than 8 cm due to morbidity obesity
- •Active systemic or cutaneous infection or inflammation
- •Prior arterial surgery in abdomen and/or lower extremities
- •Cardiogenic shock
- •Patients who are known to be pregnant or lactating.
- •Patients having a complication(s) at the femoral artery access site pre-sheath removal including hematoma, pseudoaneurysm, or arterio-venous fistula.
- •Prior femoral vascular surgery or vascular graft in region of access site.
- •Documented chronic peripheral arterial insufficiency preventing the use of the femoral technique
- •Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period.
- •Patients with known allergy to components of the device.
- •Patients who cannot adhere to or complete the investigational protocol for any reason
研究组 & 干预措施
CaveoVasc
Experimental
干预措施: CaveoVasc (Device)
结局指标
主要结局
Primary Performance Endpoint
时间窗: 30 days
Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).
时间窗: 30 days
次要结局
- Secondary Safety Endpoint(30 days)
研究者
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