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

ConditionsFemoral Artery PunctureVascular Closure DeviceHemostasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Bomaian Medical Technology Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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

Treatment groups

238 Participants
are divided into 2 treatment groups
Group A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Device Success Rate

Time frame
Intra-procedure

Secondary outcomes

1

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
2

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
3

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

Other outcomes

1

Incidence of Major Femoral Access Site Complications within 30 Days Post-Procedure

Time frame
Up to 37 days
2

Incidence of Minor Femoral Access Site Complications within 30 Days Post-Procedure

Time frame
Up to 37 days
3

Incidence of Device Deficiency

Time frame
Day 1
4

Incidence of Adverse Events

Time frame
Through study completion, an average of 2 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Bomaian Medical Technology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: