XIENCE Skypoint Large Vessel Post Approval Study
Condition(s) studied
Investigational drug(s) / intervention(s)
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): 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.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Descriptive Primary Endpoint: Target Lesion Failure (TLF) — At 1 Year
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).
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Arkansas Heart Hospital | Little Rock | Arkansas | |
| Memorial Hospital Jacksonville | Jacksonville | Florida | |
| Tallahassee Research Institute | Tallahassee | Florida | |
| Via Christi Regional Medical Center - St. Francis Campus | Wichita | Kansas | |
| Bryan Heart | Lincoln | Nebraska | |
| Lenox Hill Hospital | New York | New York | |
| Pinnacle Health System | Wormleysburg | Pennsylvania | |
| Anmed Health | Anderson | South Carolina | |
| Greenville Health System | Greenville | South Carolina | |
| Hendrick Medical Center | Abilene | Texas | |
| Austin Heart | Austin | Texas | |
| The Heart Hospital Baylor Plano | Plano | Texas | |
| Shannon Clinic | San Angelo | Texas | |
| Clinique Pasteur Toulouse | Toulouse | Midi-Pyrenees | |
| Hopital Cardiovasculaire et Pneumologique Louis Pradel | Lyon | Rhone | |
| Hospital Clinico San Carlos | Madrid | Madrid | |
| Hospital Universitario Marqués de Valdecilla | Santander | Spain | |
| Hospital Virgen de Rocio | Seville | Spain |
More Abbott Medical Devices trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05423379 on ClinicalTrials.gov ↗ ← All trials in Spain