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

NCT07279220 | Not Yet Recruiting

• 1 other identifier: BMA-202501
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoral Artery Puncture; Vascular Closure Device; Hemostasis

Outcome Measures

Primary Outcomes (1)

• Device Success Rate

  Intra-procedure

Secondary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

Test Group

EXPERIMENTAL

Device: Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd.

Control Group

ACTIVE COMPARATOR

Device: MynxGrip Vascular Closure Device Manufactured by Cordis US Corp

Interventions

Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. DEVICE

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

Test Group

MynxGrip Vascular Closure Device Manufactured by Cordis US Corp DEVICE

The control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture

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 interventional diagnostic or therapeutic procedures via femoral artery puncture;
• 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);
• 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.

You may not qualify if:

• Subjects with femoral artery occlusion or visually estimated lumen diameter \<5mm;
• Subjects with prior surgical procedures, percutaneous transluminal angioplasty (PTA), stent placement, or vascular grafts at the access site;
• Subjects with visible calcification at the access site, clinically significant peripheral vascular disease (requiring intervention), or stent implantation ≤1cm from the puncture site;
• 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;
• Subjects with posterior wall vascular puncture or multiple femoral artery punctures due to difficulty in obtaining vascular access;
• Patients with pathological obesity (BMI \>40 kg/m²);
• 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;
• Subjects with acute ST-segment elevation myocardial infarction within 48 hours prior to the procedure;
• Subjects with uncontrolled hypertension during closure (Systolic BP \>180 mmHg or Diastolic BP \>110 mmHg);
• Subjects who are known to be contraindicated or allergic to iodine-containing contrast agents or polyethylene glycol materials;
• Subjects with severe thrombocytopenia (Platelet count \<30×10⁹/L), hemophilia, von Willebrand disease, or severe anemia (Hemoglobin \<10 g/dL, Hematocrit \<30%);
• International normalized ratio (INR) \>1.5;
• Subjects with systemic infection or skin infection at the puncture site, or planned indwelling sheath;
• Subjects unable to ambulate 6 meters without assistance;
• Pregnant or lactating women;

Sponsors & Collaborators

• Shanghai Bomaian Medical Technology Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital of Army Medical University (PLA)

Chongqing, 400037, China

Location

Central Study Contacts

Qingwu Yang

CONTACT

+86-13657638868; yangqwmlys@163.com

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: November 18, 2025
• First Posted: December 12, 2025
• Study Start: December 29, 2025
• Primary Completion: March 2, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)