Vascular ClosureNCT05822804

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

A study testing Vascular Closure Device (Tonbridge) and EXOSEAL Vascular Closure Device (Codis Corporation) in people with Vascular Closure and Endovascular Procedure, run by Ton-Bridge Medical Tech. Co., Ltd at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Vascular Closure, Endovascular Procedure, Hemostasis
What is being tested?: Vascular Closure Device (Tonbridge) and EXOSEAL Vascular Closure Device (Codis Corporation)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 228 participants
Where: 7 sitesChina
Study dates: 22 May 2023to 1 Mar 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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 locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

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

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Vascular Closure, Endovascular Procedure, Hemostasis, Femoral Artery, Puncture
Being tested: Vascular Closure Device (Tonbridge), EXOSEAL Vascular Closure Device (Codis Corporation)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05822804
Study group	Role	What they receive
experimental group	Experimental	Vascular Closure Device (Tonbridge) Receives: Device: Vascular Closure Device (Tonbridge)
control group	Active comparator	EXOSEAL Vascular Closure Device (Codis Corporation) Receives: Device: EXOSEAL Vascular Closure Device (Codis Corporation)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: intra-procedure

Secondary outcomes (5)

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.
Measured: intra-procedure
Incidence of complications associated with femoral artery access
"Incidence of complications associated with femoral artery access" is the proportion of subjects with femoral artery access complications using the investigational device or the comparator.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30±7 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 20231 Mar 2024

First posted21 Apr 2023
Study start22 May 2023
Primary completion27 Jan 2024
Study completion1 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Vascular ClosureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 228 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05822804
Sponsor's protocol ID: ZHTQ202204
Status last verified: Sep 2024
First submitted: 5 Apr 2023
Last updated: 23 Jul 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vascular Closure trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05822804
Acronym / sponsor ID: ZHTQ202204
Conditions: Vascular Closure, Endovascular Procedure, Hemostasis, Femoral Artery, Puncture
Study type: Interventional
Recruitment status: Completed
Enrolment: 228 participants (actual)
Lead sponsor: Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
Study start: 22 May 2023 (actual)
Primary completion: 27 Jan 2024 (actual)
Study completion: 1 Mar 2024 (actual)
First posted: 21 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
experimental group	Experimental	Device: Vascular Closure Device (Tonbridge)Vascular Closure Device (Tonbridge)
control group	Active comparator	Device: EXOSEAL Vascular Closure Device (Codis Corporation)EXOSEAL Vascular Closure Device (Codis Corporation)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (15 listed)

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.;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vascular Closure Device (Tonbridge)Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).	Device	experimental group
EXOSEAL Vascular Closure Device (Codis Corporation)Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).	Device	control group

Primary outcome

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.

5 secondary outcomes

Time to hemostasis
Time frame: intra-procedure
Incidence of complications associated with femoral artery access
Time frame: 30±7 days post-procedure
Incidence of device deficiency
Time frame: intra-procedure
Incidence of adverse events (AE)
Time frame: 30±7 days post-procedure
Incidence of serious adverse events (SAE)
Time frame: 30±7 days post-procedure

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tianxiao Li principal investigator

Henan Provincial People's Hospital

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate hemostasis success rate (time frame: intra-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05822804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.