Suture-Mediated Closure System Following Percutaneous Common Femoral Vein Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSuzhou Hengruihongyuan Medical Technology Co. LTD
About this trial
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 Percutaneous Common Femoral Vein Procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 to 80 years
Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F
Signed by the patient personally or by their legal representative on the Informed Consent Form
Disqualifiers
Known pregnancy or lactation period;
Diameter of the common femoral artery on the puncture side < 5 mm;
Concurrent participation in another clinical research study;
Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants;
Trial design
Design model
Parallel
Treatments tested in this trial
SPIDER
DeviceThe intervention utilizes the Vascular Suture System (Model: SPD-100) developed by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd., composed of a vascular suturing device and a suture trimmer. It is intended for closing percutaneous vascular puncture sites in patients undergoing interventional catheter diagnosis or treatment. For femoral artery punctures, it is compatible with 5F-21F sheaths (for sheaths \>8F, at least 2 devices and pre-embedded suture technology are required); for femoral vein punctures, it suits 5F-24F sheaths (for sheaths \>8F, at least 1 device and pre-embedded suture technology are needed).
Perclose ProGlide
DeviceThe intervention employs the Perclose ProGlide Vascular Closure System (Model: 12673) manufactured by Abbott, a clinically validated device for closing percutaneous vascular puncture sites. It is indicated for patients undergoing interventional catheter diagnosis or treatment via femoral artery puncture with 5F-21F sheaths, serving as the control in this prospective, multi-center, randomized controlled trial. The device operates by percutaneously delivering sutures through a guidewire: during or after surgery, it accesses the puncture site, deploys sutures to approximate the vascular wall, and secures the suture knot to achieve hemostasis, with the suture permanently implanted in the body.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: SPIDERExperimental treatment 1 intervention
Group B: Perclose ProGlideActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
hemostasis success rate
Time frame
within 10 minutes post-suturingSponsors and contacts
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Source ClinicalTrials.gov