Abbott Vascular Xience Nano everolimus-eluting stent SPIRIT Study
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General
Application Number
P070015 S054
Current Protocol Accepted
05/24/2011
Study Name
SPIRIT Small Vessel (SV) Registry
Study Status
Completed
General Study Protocol Parameters
Study Design
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) Yes
Data Source
Sponsor Registry
Comparison Group
Objective Performance Criterion
Analysis Type
Analytical
Study Population
Transit. Adolescent B (as adults) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description
Prospective, single-arm, open-label, US multicenter registry study to evaluate the safety
and effectiveness of the
Sample Size
150 subjects enrolled at up to 75 sites in the
United States
Data Collection
The primary endpoint is the composite rate of
cardiac death, target vessel myocardial
infarction (MI)
Followup Visits and Length of Followup
Clinical F/U: 30 days (clinic visit), 240 days
and 1 year (clinic visit), 2, 3
Final Study Results
Actual Number of Patients Enrolled
150
Actual Number of Sites Enrolled
33
Patient Followup Rate
88.2%
Final Safety Findings
The overall (0 - 1123 days) definite/probable
stent thrombosis rate per ARC was 1.5%
(2/130).
Final Effectiveness Findings
-MACE Rates at 3 years: 12.1% (16/132)
-TVR rates at 3 years: 13.6% (18/132)
-TLF rates at
Study Strengths and Weaknesses
Results provide further evidence of the clinical
utility and safety of this device. The study
had an acceptable rate of attrition, thus
minimizing selection bias.
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Recommendations for Labeling Changes
A labeling change is recommended to add a
summary of the post-approval study results
including