To access the safety and performance of the XPro System to facilitate hemostasis in patients undergoing percutaneous endovascular procedures utilizing 8-18 Fr introducer sheath via the common femoral.
This is a prospective multi-center, single arm study to assess the safety and performance of the XPro System compared to a historical control developed from published studies of two marketed competitive devices, Perclose ProGlide® and Prostar® XL (both from Abbott Vascular, Inc., Redwood City, CA, USA). The goal of the study is to show that XPro System is non-inferior to the competitors in efficacy and safety. Patients scheduled for percutaneous BAV, TAVR/TAVI, EVAR, or TEVAR procedures using an 8-18 Fr introducer sheath will be screened for study eligibility. Patients will be followed for 30 days post procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Implantation of the XPro System
Royal North Shore Hospital
St Leonards, New South Wales, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Auckland City Hospital
Auckland, New Zealand
Christchurch Hosptial
Christchurch, New Zealand
Time to Hemostasis
Time to hemostasis absent of any access-site-related adjunctive surgical or endovascular procedures.
Time frame: 15 minutes
Freedom from major VARC-2 events
Freedom from major VARC-2 events within 30 days of the procedure.
Time frame: Up to 30 days of procedure
Freedom from minor VARC-2 events
Freedom from minor VARC-2 events up to 30 days of the procedure.
Time frame: Up to 30 days of procedure
Successful hemostasis with the XPro System
Without the need for any access-site-related adjunctive surgical or endovascular procedures and freedom from major VARC-2 events.
Time frame: at 48 hours or at discharge from hospital, whichever comes first; and up to 30 days post-procedure
Freedom from access-site infection
Freedom from access-site infection requiring IV or IM antibiotics, or extended hospitalization or re-hospitalization.
Time frame: Up to 30 days of procedure
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Waikato Hospital
Hamilton, New Zealand
China Medical University Hospital
Taichung, Taiwan