Transfemoral Puncture
Conditions
Interventions
Experimental group:APT Suture-Mediated Closure System
Control group:Perclose ProGlide Suture-Mediated Closure System
Sponsors
Guangdong Provincial People 's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~80 years old 2. It is planned to use 5F~21F puncture sheath through common femoral artery puncture for endovascular interventional diagnosis or treatment 3. Sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Any of the following exist in the ipsilateral category (lower extremity/common femoral artery/iliac artery) using the tested device: (1) The common femoral artery puncture site has undergone surgery, vascular grafting or stent implantation in the past (2) Previous use of a permanent closure device to close the common femoral artery puncture site (3) Use of any occlusion device within 90 days prior to surgery to close the common femoral artery puncture site (4) Previous lower limb amputation (5) Local infection in the groin (6) Nerve damage in the lower limbs (7) Severe peripheral arterial disease (Rutherford grade 4-6 or iliac/common femoral artery stenosis >50%) (8) Endovascular intervention or surgery of the lower extremity is planned within 30 days after this interventional surgery (9) The number of common femoral artery punctures during this operation >=2 times (10) The diameter of the common femoral artery at the puncture site =2 femoral artery sheaths or femoral vein sheaths 2. Stroke or myocardial infarction within the past 3 months 3. Known allergy to contrast agent and test device 4BMI>=40kg/m^2 5. Systemic infection 6. Platelet count 2.0 7. Major interventional treatment or surgical operation planned to be performed within 30 days after this interventional surgery 8. Life expectancy is less than 1 year 9. Females of childbearing age who are lactating, pregnant or planning to become pregnant 10. Mental abnormality or history of mental illness resulting in involuntary cooperation 11. Currently participating in other interventional clinical trials 12. The investigator judged that it was not suitable for inclusion in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis Success;Incidence of major adverse events at the puncture site within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostatic Time;Device Success ;Procedure success;Incidence of minor vascular complications at the puncture site within 30 days;Adverse Event Rate;Serious Adverse Event Rate;Incidence of Device Defects; | — |
Countries
China
Contacts
Public ContactLuo Jianfang
Guangdong Provincial People's Hospital
Outcome results
None listed