Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral… (NCT05822804) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture
China228 participantsStarted 2023-05-22
Plain-language summary
The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.
Who can participate
Age range18 Years – 80 Years
SexALL
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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 \<100Ă—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 arter…