Hemostasis after transfemoral puncture intervention
Conditions
Interventions
Test group :The test group used the hydrogel vascular puncture sealing system produced by Shanghai Yismiao Medical Equipment Co., Ltd. for treatment
Control group :The control group was treated with the EXOSEAL Vascular Closure Device, a blocking hemostatic system made by Contis' Cordis Corporation
Sponsors
The Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old <= age <= 80 years old, gender is not limited; 2. Patients undergoing interventional diagnosis and treatment surgery through femoral artery puncture; 3. Patients who use 5F to 8F for interventional diagnosis and treatment and have an effective length of 12cm sheath <= (Note: patients using 5F-7F sheath will enter the main cohort randomized control part, and patients using 8F sheath will directly enter the single-group observation part); 4. Subjects 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 lumen diameter 40kg/m^2); 7. Patients with evidence of hematoma, arteriovenous fistula or pseudoaneurysm at the entry site before vascular closure; 8. Patients receiving thrombolytic therapy (such as streptokinase, urokinase, t-PA) within 24 hours before vascular closure; 9. Patients who have received bivalirudin or low molecular weight heparin within 24 hours before puncture arterial surgery; 10. Patients with acute ST-segment elevation myocardial infarction within 48 hours before surgery; 11. Patients with hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure >110mmHg) that cannot be controlled by the drug; 12. Patients who are known to be contraindicated or allergic to iodine-containing contrast agents, polyethylene glycol materials, and polyglycolic acid materials; 13. Patients with severe thrombocytopenia (PLT1.5 or patients currently using glycoprotein IIb/IIIa platelet inhibitors; 15. Patients with known systemic infection or skin infection at the puncture site known before surgery, or patients who plan to have an indwelling sheath at the puncture site; 16. Pregnant or lactating women; 17. Patients who are participating in clinical trials of other drugs or medical devices; 18. Other patients judged by the investigator to be unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 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 |
|---|---|
| The amount of blood lost during vascular closure;Time to stop bleeding; | — |
Countries
China
Contacts
Public ContactXiao Guodong
The Second Affiliated Hospital of Soochow University
Outcome results
None listed