Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture
Vascular Closure, Endovascular Procedure, Hemostasis

About this trial
This is an interventional treatment trial for Vascular Closure
Eligibility Criteria
Inclusion Criteria: Age 18-80, male or non-pregnant female; Subjects undergoing unilateral femoral artery retrograde puncture for angiography or interventional procedure; Using guide sheath ≥5F to ≤8F, and length ≤12cm in angiography or interventional procedure; Subjects or their legal guardians voluntarily participate in this study, can complete follow-ups, and sign the informed consent form. Exclusion Criteria: Ipsilateral common femoral artery occlusion or lumen diameter < 5mm; Inability to walk; Allergy to contrast media; Allergy to PGA or PEG; subjects with a history of common femoral artery surgery, percutaneous transluminal angioplasty (PTA), stent implantation, or vascular graft; Subjects with bleeding tendency, such as thrombocytopenia (platelet count <100×109/L), hemophilia, von willebrand diseases, pre-procedure INR >1.5, etc.; Subjects have taken anticoagulants for a long term before the procedure and have blood coagulation disorders; BMI >40kg/m^2; Subjects receive thrombolytic therapy (such as streptokinase, urokinase, t-PA) within≤24 hours before vascular closure; Local infections or skin infections of the investigational limb; Subjects with target femoral artery dissection or aneurysm within 30 days before intervention procedure; Subjects with puncture site have been punctured through the posterior wall of the femoral artery, or have been punctured several times (≥3 times), or have bleeding or hematoma on the femoral artery puncture site during the procedure; Subjects with clinically significant peripheral vascular diseases (such as severe calcification, arteritis, stenosis, etc) near the puncture site; Women who are pregnant or breastfeeding, OR men or women who plan to have a child in the next 6 months; Subjects who are enrolled in other clinical trials and don't complete; Subjects are considered not suitable for enrollment by the investigators.
Sites / Locations
- The First Affiliated Hospital of Wannan Medical College
- Nanyang Central Hospital
- Puyang Oilfield General Hospital
- Henan Provincial People's Hospital
- The Second Affiliated Hospital of Soochow University
- General Hospital of Northern Theater Command
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
experimental group
control group
Vascular Closure Device (Tonbridge)
EXOSEAL Vascular Closure Device (Codis Corporation)