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

Hemostasis Clinical Trial

Official title:

Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05822804
• Other study ID #: ZHTQ202204
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Contact: Heng Wang
• Phone: 18826260512
• Email: heng.wang[@]ton-bridge.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Artery
• Hemostasis
• Puncture
• Vascular Closure
• Wounds and Injuries

Intervention

Device:
• Vascular Closure Device (Tonbridge)
Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).
• EXOSEAL Vascular Closure Device (Codis Corporation)
Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Nanyang Central Hospital	Nanyang	Henan
China	Puyang Oilfield General Hospital	Puyang	Henan
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate hemostasis success rate	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.	intra-procedure
Secondary	Time to hemostasis	The time it takes (unit: minute) to reach no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site, once completing the closure operation of femoral artery puncture site using vascular closure device.	intra-procedure
Secondary	Time to ambulation	The time it takes (unit: hour) to get out of bed and walk at least 6 meters or 20 feet, once completing the closure operation of femoral artery puncture site using vascular closure device.	pre-discharge, estimate to 24 hours post-procedure
Secondary	Incidence of complications associated with femoral artery access	The complications include: infection associated with the puncture site, bleeding requiring hemostasis treatment associated with the puncture site, hematoma or ecchymosis =6cm on the puncture site, haemorrhage and/or bleeding requiring transfusion, pseudoaneurysm, arteriovenous fistula, etc.	30±7 days post-procedure
Secondary	Incidence of device deficiency	Device deficiency is the unreasonable risk that may endanger human health and life safety under normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions, etc.	intra-procedure
Secondary	Incidence of adverse events (AE)	"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.	30±7 days post-procedure
Secondary	Incidence of serious adverse events (SAE)	"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.	30±7 days post-procedure