CompletedNot Applicable

Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

China135 participantsStarted 2023-06-01

Plain-language summary

The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Aged 18-80
✓. Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
✓. Informed consent signed by the patient or legal representative

Exclusion criteria

✕. Pregnancy or lactation period;
✕. Diameter of femoral artery site for puncture\< 5mm;
✕. Have participated in another clinical study during the same period;
✕. Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
✕. Vascular injury at the site of the approach;
✕. Groin infection;
✕. Morbid obesity (BMI≥40kg / ㎡);
✕. Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;

What they're measuring

Rate of successful hemostasis

Timeframe: 10 minutes

Trial details

NCT IDNCT05899478

SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Percutaneous Intervention Via Femoral Artery trials