None
Conditions
Interventions
Experimental group:Embedded suture vessel closure system
Control group:Perclose ProGlide Suture- Mediated Closure System
Sponsors
Hefei High-Tech Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old = age =85 years old, gender is not limited; 2. Patients who choose or plan to use the 5F to 21F guide sheath for femoral artery diagnosis and interventional catheter surgery; 3. Patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion criteria
Exclusion criteria: 1. The right anterior oblique and left anterior oblique femoral artery angiography confirmed that the puncture site was above the lowermost boundary of the inferior abdominal artery, above the inguinal ligament, the superficial femoral artery, the deep femoral artery, or when such vessels bifurcated; 2. Preoperative color Doppler ultrasound confirmed that the femoral artery on the puncture side was severely calcified (=50%) or thin (diameter 40 kg/m2); 7. Systemic infection or local infection at or near the contact site; 8. Difficult to control hypertension (blood pressure =220/110mmHg); 9. Cerebrovascular accident or myocardial infarction within three months; 10. Femoral artery aneurysm, arteriovenous fistula or false aneurysm; 11. Traumatic vascular injury at the site of the approach; 12. Hematoma at ipsilateral artery approach; 13. Need to receive thrombolytic therapy; 14. Life expectancy less than 30 days; 15. Puncture of the femoral artery in the target groin within 30 days prior to surgery and/or previous placement of a vascular closing device in the target femoral artery, which the investigator considered might interfere with the test; 16. Previous interventions in the approach area, including but not limited to atherectomy, stenting, surgery, or transplantation in the approach area; 17. Permanent implant closure of the ipsilateral femoral artery; 18. Previously received vascular transplantation or surgery at the site of the target vascular access; 19. Arterial catheters need to be set at the site of the approach; 20. Femoral vein sheath should be used on the same side; 21. Ipilateral femoral artery puncture intervention was performed within 30 days before surgery or planned for the next 30 days; 22. Contraindications of contrast agents or anticoagulants; 23. Known allergy to any equipment component; 24. Pregnant and lactating women; 25. Other situations that the investigator judged unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major complications at the site of approach; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostasis time;Instrument success rate;Success rate of vascular closure by approach;The incidence of secondary complications at the approach site;Adverse events/serious adverse events rate;Incidence of device defect; | — |
Countries
China
Contacts
Public ContactMei Ju
Hefei High-Tech Cardiovascular Hospital
Outcome results
None listed