CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 102 enrolled
Drug / intervention
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05423379
NCT05423379N/AActive
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XIENCE Skypoint Large Vessel Post Approval Study

Abbott Medical Devices·observational·Posted Jun 21, 2022·Updated Feb 24, 2026

In Brief

An observational study evaluating XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) for Coronary Artery Disease. Active but no longer recruiting, targeting 102 participants across 18 sites in 3 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesFrance, Spain, United States
Collaborators--

Timeline

N/AActive
20232024202520262027
First PostedJun 21, 2022
Enrollment StartSep 14, 2022
Primary CompletionNov 20, 2024
Study CompletionAug 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.0 years ago

Interventions

XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)device

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.