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

NCT05822804 | Completed

• 1 other identifier: ZHTQ202204
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to hemostasis

  intra-procedure

• Incidence of complications associated with femoral artery access

  30±7 days post-procedure

• Incidence of device deficiency

  intra-procedure

• Incidence of adverse events (AE)

  30±7 days post-procedure

• Incidence of serious adverse events (SAE)

  30±7 days post-procedure

Study Arms (2)

experimental group

EXPERIMENTAL

Vascular Closure Device (Tonbridge)

Device: Vascular Closure Device (Tonbridge)

control group

ACTIVE COMPARATOR

EXOSEAL Vascular Closure Device (Codis Corporation)

Device: EXOSEAL Vascular Closure Device (Codis Corporation)

Interventions

Vascular Closure Device (Tonbridge) DEVICE

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

experimental group

EXOSEAL Vascular Closure Device (Codis Corporation) DEVICE

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

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (7)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Nanyang Central Hospital

Nanyang, Henan, China

Location

Puyang Oilfield General Hospital

Puyang, Henan, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Vascular Closure Devices

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Tianxiao Li

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 21, 2023
• Study Start: May 22, 2023
• Primary Completion: January 27, 2024
• Study Completion: March 1, 2024
• Last Updated: July 23, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)