NCT07279220尚未招募不适用
A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Device Success Rate
研究概览
简要总结
The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of 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 interventional diagnostic or therapeutic procedures via femoral artery puncture;
- •Subjects using 5F to 8F sheaths during the procedure (Note: Subjects using 5F-7F sheaths will enter the main randomized controlled cohort, while subjects using 8F sheaths will directly enter the single-arm observational cohort);
- •Subjects or their legally authorized representatives can understand the purpose of the trial, voluntarily participate in the trial and sign informed consent form, and be able and willing to comply with follow-ups and related procedures.
排除标准
- •Subjects with femoral artery occlusion or visually estimated lumen diameter <5mm;
- •Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site;
- •Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site;
- •Subjects whose puncture site is above the lowest edge of the inferior epigastric artery and/or above the inguinal ligament as identified by skeletal markers;
- •Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access;
- •Patients with pathological obesity (BMI >40 kg/m²);
- •Subjects with pre-existing access site complications (hematoma, pseudoaneurysm, arteriovenous fistula, dissection, etc) or any procedure-related complications that may affect recovery, ambulation, or discharge timing;
- •Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure;
- •Subjects with uncontrolled hypertension during closure (Systolic BP >180 mmHg or Diastolic BP >110 mmHg);
- •Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials;
- •Subjects with severe thrombocytopenia (Platelet count <30×10⁹/L), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin <10 g/dL, Hematocrit <30%);
- •International normalized ratio (INR) >1.5;
- •Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath;
- •Subjects unable to ambulate 6 meters without assistance;
- •Pregnant or lactating women;
- •Subjects currently participating in other drug/device clinical trials;
- •Other subjects deemed ineligible for this clinical trial by the investigator.
结局指标
主要结局
Device Success Rate
时间窗: Intra-procedure
次要结局
- Time to Hemostasis(Time from completion of femoral artery puncture site closure operation using the vascular closure device system to achievement of hemostasis, which will be assessed up to 1 day)
- Time to Ambulation(Time from completion of femoral artery puncture site closure operation using the vascular closure device system to the patient's ability to ambulate at least 6 meters, which will be assessed up to 30 days)
- Time to Hospital Discharge(Time from completion of femoral artery puncture site closure operation using the vascular closure device system to Hospital discharge determined by physician, which will be assessed up to 30 days)
研究者
研究点 (1)
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