Percutaneous Intervention Via Common Femoral Vein
Conditions
Brief 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 Percutaneous Common Femoral Vein Procedures.
Detailed description
Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.
Interventions
DEVICESPIDER
The 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).
DEVICEPerclose ProGlide
The 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.
Sponsors
Suzhou Hengruihongyuan Medical Technology Co. LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 80 years 2. Patients eligible for interventional catheter-based examination or treatment via common femoral artery puncture using sheaths sized 5F to 21F 3. Signed by the patient personally or by their legal representative on the Informed Consent Form
Exclusion criteria
1. Known pregnancy or lactation period; 2. Diameter of the common femoral artery on the puncture side \< 5 mm; 3. Concurrent participation in another clinical research study; 4. Known allergy to any device component, and/or contraindications to contrast agents or anticoagulants; 5. Vascular injury at the access site; 6. Infection of the inguinal puncture site; 7. Morbid obesity (BMI ≥ 40 kg/m²); 8. Lower extremity vascular ultrasound for assessment of common femoral artery stenosis ≥50%; 9. Presence of femoral artery aneurysm, arteriovenous fistula, or pseudoaneurysm in the common femoral artery; 10. Previous use of clip-based vascular closure devices at the ipsilateral arterial access site; 11. Hematoma at the ipsilateral arterial access site; 12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemostasis success rate | within 10 minutes post-suturing |
Countries
China
Contacts
CONTACTFu Weiguo Fu
Outcome results
None listed