Clinical trial NCT05822804: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Closure
Endovascular Procedure
Hemostasis
Femoral Artery
Puncture
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Immediate hemostasis success rate
timeFrame: intra-procedure
Secondary outcomes:
measure: Time to hemostasis
timeFrame: intra-procedure
measure: Time to ambulation
timeFrame: pre-discharge, estimate to 24 hours post-procedure
measure: Incidence of complications associated with femoral artery access
timeFrame: 30±7 days post-procedure
measure: Incidence of device deficiency
timeFrame: intra-procedure
measure: Incidence of adverse events (AE)
timeFrame: 30±7 days post-procedure
measure: Incidence of serious adverse events (SAE)
timeFrame: 30±7 days post-procedure
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Puyang
country: China
facility: Puyang Oilfield General Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Henan Provincial People's Hospital
name: Tianxiao Li
role: PRINCIPAL_INVESTIGATOR
References: