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

Primary Purpose

Vascular Closure, Endovascular Procedure, Hemostasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vascular Closure Device (Tonbridge)
EXOSEAL Vascular Closure Device (Codis Corporation)
Sponsored by
Zhuhai Tonbridge Medical Tech. Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Closure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Wannan Medical College
  • Nanyang Central Hospital
  • Puyang Oilfield General Hospital
  • Henan Provincial People's Hospital
  • The Second Affiliated Hospital of Soochow University
  • General Hospital of Northern Theater Command
  • The Second Affiliated Hospital Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

Vascular Closure Device (Tonbridge)

EXOSEAL Vascular Closure Device (Codis Corporation)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Incidence of adverse events (AE)
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
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.

Full Information

First Posted
April 5, 2023
Last Updated
April 20, 2023
Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05822804
Brief Title
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Tonbridge Medical Tech. Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Closure, Endovascular Procedure, Hemostasis, Femoral Artery, Puncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Vascular Closure Device (Tonbridge)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
EXOSEAL Vascular Closure Device (Codis Corporation)
Intervention Type
Device
Intervention Name(s)
Vascular Closure Device (Tonbridge)
Intervention Description
Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).
Intervention Type
Device
Intervention Name(s)
EXOSEAL Vascular Closure Device (Codis Corporation)
Intervention Description
Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).
Primary Outcome Measure Information:
Title
Immediate hemostasis success rate
Description
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.
Time Frame
intra-procedure
Secondary Outcome Measure Information:
Title
Time to hemostasis
Description
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.
Time Frame
intra-procedure
Title
Time to ambulation
Description
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.
Time Frame
pre-discharge, estimate to 24 hours post-procedure
Title
Incidence of complications associated with femoral artery access
Description
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.
Time Frame
30±7 days post-procedure
Title
Incidence of device deficiency
Description
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.
Time Frame
intra-procedure
Title
Incidence of adverse events (AE)
Description
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Time Frame
30±7 days post-procedure
Title
Incidence of serious adverse events (SAE)
Description
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Time Frame
30±7 days post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heng Wang
Phone
18826260512
Email
heng.wang@ton-bridge.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianing Zhang
Phone
13941826987
Email
jn.zhang@ton-bridge.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tianxiao Li
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Wannan Medical College
City
Wuhu
State/Province
Anhui
Country
China
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
Country
China
Facility Name
Puyang Oilfield General Hospital
City
Puyang
State/Province
Henan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinzhao Liu
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guodong Xiao
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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