Femoral Artery PunctureNCT07279220
Safety and Effectiveness of the Vascular Closure Device for Femoral Artery Hemostasis in Patients of Femoral Artery Puncture
A study testing Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. and MynxGrip Vascular Closure Device Manufactured by Cordis US Corp in people with Femoral Artery Puncture and Vascular Closure Device, run by Shanghai Bomaian Medical Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Femoral Artery Puncture, Vascular Closure Device, Hemostasis
- What is being tested?
- Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. and MynxGrip Vascular Closure Device Manufactured by Cordis US Corp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2025to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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.
Who cannot join
- 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);
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- 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;
- Subjects currently participating in other drug/device clinical trials;
- Other subjects deemed ineligible for this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Army Medical University (PLA)
Chongqing, 400037
About this study
Official title: 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.
- Conditions
- Femoral Artery Puncture, Vascular Closure Device, Hemostasis
- Being tested
- Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd., MynxGrip Vascular Closure Device Manufactured by Cordis US Corp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
MynxGrip Vascular Closure Device Manufactured by Cordis US CorpDevice
The control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Not described Receives: Device: Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. |
| Control Group | Active comparator | Not described Receives: Device: MynxGrip Vascular Closure Device Manufactured by Cordis US Corp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success Rate
Measured: Intra-procedure
Secondary outcomes (3)
Time to Hemostasis
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start29 Dec 2025 (estimated)
- Primary completion2 Mar 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery PunctureStudies 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
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279220
- Sponsor's protocol ID
- BMA-202501
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07279220
- Acronym / sponsor ID
- BMA-202501
- Conditions
- Femoral Artery Puncture, Vascular Closure Device, Hemostasis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Shanghai Bomaian Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2025 (estimated)
- Primary completion
- 2 Mar 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 12 Dec 2025 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
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 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.
Key exclusion criteria (17 listed)
- 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;
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 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 | Device | Test Group |
| MynxGrip Vascular Closure Device Manufactured by Cordis US CorpThe control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture | Device | Control Group |
Primary outcome
Device Success Rate
Time frame: Intra-procedure
3 secondary outcomes
Time to Hemostasis
Time frame: 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 frame: 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 frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. and MynxGrip Vascular Closure Device Manufactured by Cordis US Corp in people with Femoral Artery Puncture and Vascular Closure Device, run by Shanghai Bomaian Medical Technology Co., Ltd at 1 site in China.
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 17 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: opening soon, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingwu Yang (+86-13657638868, yangqwmlys@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device 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?
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 12 Dec 2025.