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
366
Vascular Closure
Manual compression is a commonly used method to achieve hemostasis of femoral artery
Beijing Tiantan Hospital Capitol Medical University
Beijing, China
Time to hemostasis
To evaluate whether the time to hemostasis for the puncture site of common femoral artery of the subjects in the MynxGrip group is superior to the control group. Determined using the following formula where time is measured in minutes. H0: ttest - tcontrol ≥ -5,H1: ttest - tcontrol \< -5
Time frame: Intraoperatively
Time to ambulation
Compare whether there are statistical differences between the test and control group in the time to ambulation measured in hours and determined using a t-test analysis
Time frame: At time of procedure through discharge (up to 3 days post procedure)
Length of hospital stay
Compare whether there are statistical differences between the test and control group in the length of the hospital stay measured in hours and using a t-test analysis.
Time frame: Up to 5 days post procedure
Procedure Success Rate
Chi-squared Test or Fisher's Exact Test is used, according to the distribution characteristics.
Time frame: Intraoperatively
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