Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture

The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemostasis; Femoral Artery Puncture; Vascular Closure Device
• Intervention / Treatment: Device: Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd.; Device: MynxGrip Vascular Closure Device Manufactured by Cordis US Corp

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingwu Yang; Phone Number: +86-13657638868; Email: yangqwmlys@163.com

Study Locations

• China
  • Chongqing, China, 400037
    • The Second Affiliated Hospital of Army Medical University (PLA)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18~80, male or non-pregnant female;
2. Subjects undergoing interventional diagnostic or therapeutic procedures via femoral artery puncture;
3. Subjects using 5F to 8F sheaths during the procedure (Note: Subjects using 5F-7F sheaths will enter the main randomized controlled cohort, while subjects using 8F sheaths will directly enter the single-arm observational cohort);
4. Subjects or their legally authorized representatives can understand the purpose of the trial, voluntarily participate in the trial and sign informed consent form, and be able and willing to comply with follow-ups and related procedures.

Exclusion Criteria:

1. Subjects with femoral artery occlusion or visually estimated lumen diameter <5mm;
2. Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site;
3. Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site;
4. Subjects whose puncture site is above the lowest edge of the inferior epigastric artery and/or above the inguinal ligament as identified by skeletal markers;
5. Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access;
6. Patients with pathological obesity (BMI >40 kg/m²);
7. Subjects with pre-existing access site complications (hematoma, pseudoaneurysm, arteriovenous fistula, dissection, etc) or any procedure-related complications that may affect recovery, ambulation, or discharge timing;
8. Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure;
9. Subjects with uncontrolled hypertension during closure (Systolic BP >180 mmHg or Diastolic BP >110 mmHg);
10. Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials;
11. Subjects with severe thrombocytopenia (Platelet count <30×10⁹/L), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin <10 g/dL, Hematocrit <30%);
12. International normalized ratio (INR) >1.5;
13. Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath;
14. Subjects unable to ambulate 6 meters without assistance;
15. Pregnant or lactating women;
16. Subjects currently participating in other drug/device clinical trials;
17. Other subjects deemed ineligible for this clinical trial by the investigator.

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
Active Comparator: Control Group	Device: MynxGrip Vascular Closure Device Manufactured by Cordis US Corp; The control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture
Experimental: Test Group	Device: Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd.; The test group will use the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Device Success Rate	Intra-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to Hemostasis	Time from completion of femoral artery puncture site closure operation using the vascular closure device system to achievement of hemostasis, which will be assessed up to 1 day
Time to Ambulation	Time from completion of femoral artery puncture site closure operation using the vascular closure device system to the patient's ability to ambulate at least 6 meters, which will be assessed up to 30 days
Time to Hospital Discharge	Time from completion of femoral artery puncture site closure operation using the vascular closure device system to Hospital discharge determined by physician, which will be assessed up to 30 days

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Major Femoral Access Site Complications within 30 Days Post-Procedure	Up to 37 days
Incidence of Minor Femoral Access Site Complications within 30 Days Post-Procedure	Up to 37 days
Incidence of Device Deficiency	Day 1
Incidence of Adverse Events	Through study completion, an average of 2 months
Incidence of Serious Adverse Events	Through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Shanghai Bomaian Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 29, 2025
• Primary Completion (Estimated): March 2, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 30, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: November 30, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BMA-202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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