Femoral Artery Puncture Site Closure for Hemostasis
Conditions
Interventions
Experimental group:Use a blocking hemostat produced by Hangzhou Juzheng Medical Technology Co., Ltd. for treatment
Control group:Treatment was performed using the EXOSEAL Vascular Closure Device, an occlusion hemostasis system manufactured by Cordis Corporation
Single arm Observation group:used the VCD(8F)produced by Hangzhou Matrix Medical Technology Co., Ltd. for treatment
Sponsors
The First People’s Hospital of Changzhou
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, gender is not limited; 2. Patients undergoing diagnostic or interventional surgery through femoral artery puncture; 3. Patients using 5F-8F sheaths with effective length <=12cm (Note: patients using 5F-7F sheaths will enter the main cohort randomized control part, and patients using 8F sheaths will directly enter the single-group observation part); 4. Patients who voluntarily participate in the trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with common femoral artery occlusion or visual luminal diameter 40kg/m^2); 8. Patients who received thrombolytic therapy (such as streptokinase, urokinase, t-PA) 1.5 or severe thrombocytopenia (PLT 180mmHg or diastolic blood pressure >110mmHg); 13. Patients with known contraindications or allergies to iodine-containing contrast agents, polyglycolic acid, and gum raw materials; 14. Patients with known systemic infection or skin infection at the puncture site before surgery; 15. Pregnant or lactating women; 16. Patients who are participating in clinical trials of other drugs or medical devices; 17. Other patients who are not suitable for participating in this clinical trial as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The the collagen patch/hemostatic plug is in place and the operation is successful;Hemostasis time <=5 min;The delivery system was completely withdrawn from the body, and no complications related to the test instrument occurred during the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemostasis time;Absorption status of the collagen patch/hemostatic plug at 96 days after surgery (if applicable); | — |
Countries
China
Contacts
Public ContactPeng Ya
The First People’s Hospital of Changzhou
Outcome results
None listed