Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Closure
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Enrollment
- 228
- Locations
- 7
- Primary Endpoint
- Immediate hemostasis success rate
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief 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.
Detailed Description
This is a prospective, multicenter, randomized control, non-inferiority clinical trial carried out in 7 centers throughout China. 228 subjects with hemostasis of femoral artery puncture will be treated with the Vascular Closure Device (Tonbridge) or the EXOSEAL Vascular Closure Device (Codis Corporation). The primary objective of this study is to evaluate the safety and effectiveness of the vascular closure device in hemostasis treatment for femoral artery puncture.
Investigators
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;
Outcomes
Primary Outcomes
Immediate hemostasis success rate
Time Frame: intra-procedure
Immediate hemostasis success is defined as no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site within 5 minutes, once completing the closure operation of femoral artery puncture site using vascular closure device.
Secondary Outcomes
- Time to hemostasis(intra-procedure)
- Incidence of complications associated with femoral artery access(30±7 days post-procedure)
- Incidence of device deficiency(intra-procedure)
- Incidence of adverse events (AE)(30±7 days post-procedure)
- Incidence of serious adverse events (SAE)(30±7 days post-procedure)