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

Zhuhai Tonbridge Medical Technology

Status: Completed

Conditions: Hemostasis; Puncture; Endovascular Procedure; Vascular Closure; Femoral Artery

Treatments: Device: EXOSEAL Vascular Closure Device (Codis Corporation); Device: Vascular Closure Device (Tonbridge)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05822804

ZHTQ202204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 228 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

228 participants in 2 patient groups

experimental group

Experimental group

Description:

Vascular Closure Device (Tonbridge)

Treatment:

Device: Vascular Closure Device (Tonbridge)

control group

Active Comparator group

Description:

EXOSEAL Vascular Closure Device (Codis Corporation)

Treatment:

Device: EXOSEAL Vascular Closure Device (Codis Corporation)