At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 525 enrolled
Drug / intervention
Core size Xience Prime +1 moredevice
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.
SPIRIT PRIME Clinical Trial.
In Brief
A Phase 3 clinical trial evaluating Core size Xience Prime and Xience Prime Long Lesion (LL) for Myocardial Ischemia and 4 related conditions. Completed, enrolled 525 participants across 62 sites in 2 countries.
Detailed Summary
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
CountriesAustralia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionMar 2011
Study CompletionFeb 2014
TodayJul 2026
First PostedJun 9, 2009
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2011
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.1 years ago
Interventions
Core size Xience Primedevice
Core size includes a range of stent sizes.
Xience Prime Long Lesion (LL)device
Long lesion stent sizes include a range of sizes.