The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
47
University of Lubeck Hospital
Lübeck, Germany
University of Rostock Hosptial
Rostock, Germany
Major Complications
The rate of major complications within approximately 30 days following the procedure.
Time frame: 30 days
Time-to-Hemostasis
Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding.
Time frame: Time to hemostasis will be measured as the time from removal of the guiding catheter to the time of cessation of common femoral artery bleeding, assessed up to 2 hours.
Time-to-Ambulation
The time from end of the procedure until the patient ambulates for the first time.
Time frame: Ambulation will be assessed 1.5 hours after removal of the access sheath for Diagnostic Patients, and 3 hours after procedure sheath removal for Interventional Patients.
Adverse Events
The rate of adverse events within approximately 30 days following the procedure. All AEs counted, whether or not device-related.
Time frame: 30 days
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