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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemostasis; Vascular Closure; Puncture; Femoral Artery; Endovascular Procedure
• Intervention / Treatment: Device: Vascular Closure Device (Tonbridge); Device: EXOSEAL Vascular Closure Device (Codis Corporation)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianing Zhang; Phone Number: 13941826987; Email: jn.zhang@ton-bridge.com
• Study Contact Backup: Name: Heng Wang; Phone Number: 18826260512; Email: heng.wang@ton-bridge.com

Study Locations

• China
  • Anhui
    • Wuhu, Anhui, China
      • The first affiliated hospital of Wannan Medical College
  • Henan
    • Nanyang, Henan, China
      • Nanyang Central Hospital
    • Puyang, Henan, China
      • Puyang Oilfield General Hospital
      • Principal Investigator: Jinzhao Liu
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University
      • Principal Investigator: Guodong Xiao
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theater Command
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Vascular Closure Device (Tonbridge)	Device: Vascular Closure Device (Tonbridge); Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).
Active Comparator: control group; EXOSEAL Vascular Closure Device (Codis Corporation)	Device: EXOSEAL Vascular Closure Device (Codis Corporation); Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
• Investigators: Principal Investigator: Tianxiao Li, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: ZHTQ202204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No