Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture

Exclusion Criteria

• •1. Subjects with femoral artery occlusion or visually estimated lumen diameter \<5mm;
• •2. Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site;
• •3. Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site;
• •4. 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;
• •5. Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access;
• •6. Patients with pathological obesity (BMI \>40 kg/m²);
• •7. 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;
• •8. Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure;
• •9. Subjects with uncontrolled hypertension during closure (Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg);
• •10. Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials;
• •11. Subjects with severe thrombocytopenia (Platelet count \<30×10⁹/L), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin \<10 g/dL, Hematocrit \<30%);
• •12. International normalized ratio (INR) \>1.5;
• •13. Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath;
• •14. Subjects unable to ambulate 6 meters without assistance;
• •15. Pregnant or lactating women;
• •16. Subjects currently participating in other drug/device clinical trials;
• •17. Other subjects deemed ineligible for this clinical trial by the investigator.