SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.
Study Type
OBSERVATIONAL
Enrollment
102
XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Descriptive Primary Endpoint: Target Lesion Failure (TLF)
TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR).
Time frame: At 1 Year
Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)
TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR.
Time frame: 1 year
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Tallahassee Research Institute
Tallahassee, Florida, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, United States
Bryan Heart
Lincoln, Nebraska, United States
Lenox Hill Hospital
New York, New York, United States
Pinnacle Health System
Wormleysburg, Pennsylvania, United States
Anmed Health
Anderson, South Carolina, United States
Greenville Health System
Greenville, South Carolina, United States
Hendrick Medical Center
Abilene, Texas, United States
...and 8 more locations