To evaluate the safety and effectiveness of MynxGrip, in hemostasis of common femoral artery puncture site, compared with manual compression hemostasis in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
Effectiveness: to superiority to the control group in time to hemostasis. Comparison of time to ambulation, procedure success rate, length of stay in hospital, device success rate. Safety-Major/Minor complication rate, adverse events, SAEs as compared to control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
306
Vascular Closure
Manual compression is a commonly used method to achieve hemostasis of femoral artery
Beijing Tiantan Hospital Capitol Medical University
Beijing, China
Primary Effectiveness Endpoint: Time to Hemostasis
The time to hemostasis is defined as the time from the sheath removal to the time to achieving hemostasis for the subject. The "hemostasis" here refers to that at the puncture site, there is no pulsating bleeding, nor expansionary/progressive hematoma.
Time frame: Post procedure (time from the sheath removal to the time to achieving hemostasis)
Primary Safety Endpoint: Major Complication Rate
Defined as major complications during procedure, at discharge, and 30 days post procedure: vascular injury or vascular repair required; Permanent access site-related nerve injury; Access site-related nerve injury requiring a surgery; Access site-related bleeding requiring transfusion; New ipsilateral lower extremity ischemia discovered, which requires invasive/noninvasive intervention; Local access site-related infection combined with other indicators, which requires intervention; Classic signs/symptoms occurred in a short time after receiving the specified hemostasis procedures and generalized infection with positive blood culture, sepsis, which requiring intervention; Inflammatory reaction, including the local reaction and discharge of pus, which requires intervention
Time frame: Through 30 days post procedure
Secondary Effectiveness Endpoint: Time to Ambulation
Defined as the time (in minutes) from sheath removal to when the patient can walk about at least 6 meters (or 20 steps). Compare whether there are differences in the time to ambulation (for patients receiving a diagnostic procedure) between the two groups.
Time frame: Post procedure
Secondary Effectiveness Endpoint: Length of Hospital Stay
Defined as the time (in minutes) from sheath removal to patient discharge (for patients receiving a diagnostic procedure). Compare whether there are differences in the length of stay (for patients receiving a diagnostic procedure) between the two groups.
Time frame: Index procedure through discharge
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Secondary Effectiveness Endpoint: Procedure Success Rate
Defined as successfully achieving hemostasis using the investigational medical device or control methods (including but are not limited to the assigned therapeutic method and other supplementary means) with absence of major complications. Compare whether there are differences in the procedure success rate (for patients receiving a diagnostic procedure) between the two groups.
Time frame: Index procedure
Secondary Effectiveness Endpoint: Device Success Rate
Defined as the device being successfully removed in accordance with the standard operating procedure
Time frame: Intraoperatively
Secondary Safety Endpoint: Minor Complication Rate
Compare whether there are differences in rates of minor complications between the two groups
Time frame: Through 30 days post procedure