NCT05822804已完成不适用
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Ton-Bridge Medical Tech. Co., Ltd7 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2023年5月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 7
- 主要终点
- Immediate hemostasis success rate
研究概览
简要总结
The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.
详细描述
This is a prospective, multicenter, randomized control, non-inferiority clinical trial carried out in 7 centers throughout China. 228 subjects with hemostasis of femoral artery puncture will be treated with the Vascular Closure Device (Tonbridge) or the EXOSEAL Vascular Closure Device (Codis Corporation). The primary objective of this study is to evaluate the safety and effectiveness of the vascular closure device in hemostasis treatment for femoral artery puncture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80, male or non-pregnant female;
- •Subjects undergoing unilateral femoral artery retrograde puncture for angiography or interventional procedure;
- •Using guide sheath ≥5F to ≤8F, and length ≤12cm in angiography or interventional procedure;
- •Subjects or their legal guardians voluntarily participate in this study, can complete follow-ups, and sign the informed consent form.
排除标准
- •Ipsilateral common femoral artery occlusion or lumen diameter < 5mm;
- •Inability to walk;
- •Allergy to contrast media;
- •Allergy to PGA or PEG; subjects with a history of common femoral artery surgery, percutaneous transluminal angioplasty (PTA), stent implantation, or vascular graft;
- •Subjects with bleeding tendency, such as thrombocytopenia (platelet count <100×109/L), hemophilia, von willebrand diseases, pre-procedure INR >1.5, etc.;
- •Subjects have taken anticoagulants for a long term before the procedure and have blood coagulation disorders;
- •BMI >40kg/m^2;
- •Subjects receive thrombolytic therapy (such as streptokinase, urokinase, t-PA) within≤24 hours before vascular closure;
- •Local infections or skin infections of the investigational limb;
- •Subjects with target femoral artery dissection or aneurysm within 30 days before intervention procedure;
- •Subjects with puncture site have been punctured through the posterior wall of the femoral artery, or have been punctured several times (≥3 times), or have bleeding or hematoma on the femoral artery puncture site during the procedure;
- •Subjects with clinically significant peripheral vascular diseases (such as severe calcification, arteritis, stenosis, etc) near the puncture site;
- •Women who are pregnant or breastfeeding, OR men or women who plan to have a child in the next 6 months;
- •Subjects who are enrolled in other clinical trials and don't complete;
- •Subjects are considered not suitable for enrollment by the investigators.
结局指标
主要结局
Immediate hemostasis success rate
时间窗: intra-procedure
Immediate hemostasis success is defined as no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site within 5 minutes, once completing the closure operation of femoral artery puncture site using vascular closure device.
次要结局
- Time to hemostasis(intra-procedure)
- Incidence of complications associated with femoral artery access(30±7 days post-procedure)
- Incidence of device deficiency(intra-procedure)
- Incidence of adverse events (AE)(30±7 days post-procedure)
- Incidence of serious adverse events (SAE)(30±7 days post-procedure)
- Time to hemostasis(intra-procedure)
- Incidence of complications associated with femoral artery access(30±7 days post-procedure)
- Incidence of device deficiency(intra-procedure)
- Incidence of adverse events (AE)(30±7 days post-procedure)
- Incidence of serious adverse events (SAE)(30±7 days post-procedure)
研究者
研究点 (7)
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