Percutaneous Intervention Via Femoral Artery
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 endovascular peripheral arterial 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
DEVICETyknot® Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
DEVICEPerclose® ProGlide Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
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 18-80 2. Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy 3. Informed consent signed by the patient or legal representative
Exclusion criteria
1. Pregnancy or lactation period; 2. Diameter of femoral artery site for puncture\< 5mm; 3. Have participated in another clinical study during the same period; 4. Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants; 5. Vascular injury at the site of the approach; 6. Groin infection; 7. Morbid obesity (BMI≥40kg / ㎡); 8. Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%; 9. There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery; 10. Clamp vessel closures were used at the previous ipsilateral artery approach; 11. Hematoma at ipsilateral artery approach; 12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of successful hemostasis | 10 minutes | Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%. Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis time | Approximately 15-minutes after compression | The time from the catheter sheath is removed to compression is released and no bleeding occurs at the puncture site |
| Technical success rate | Approximately 15-minutes after device removal | Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%. Definition of Technical success: Successful placement of the device,smooth withdrawal, and completion fo the knot. |
| Evaluation of Compatibility with guidewires of the device | Approximately 15-minutes after device removal | Scale from 1 point (worst) to 5 points (best) |
| Operation time | Approximately 15-minutes after device removal | The time for suturing with the vascular closure device. Definition of Operation time: The time it takes for the device to enter the artery, tie the knot, and then be successfully withdrawn from the vessel. |
| Evaluation of Withdrawal performance of the device | Approximately 15-minutes after device removal | Scale from 1 point (worst) to 5 points (best) |
| Evaluation of Performance of tightening knot of the device | Approximately 15-minutes after device removal | Scale from 1 point (worst) to 5 points (best) |
| Evaluation of Pushing performance of the device | Approximately 15-minutes after device removal | Scale from 1 point (worst) to 5 points (best) |
Countries
China
Outcome results
None listed