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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P070015 S054/ PAS001 |
| Date Original Protocol Accepted |
05/24/2011
|
| Date Current Protocol Accepted |
05/24/2011
|
| Study Name |
SPIRIT Small Vessel (SV) Registry
|
| Device Name |
XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM
|
| Clinical Trial Number(s) |
NCT00180310
NCT00180453
NCT00180479
NCT00307047
NCT00676520
NCT00783796
NCT01106534
NCT01120379
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| 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 Objectives |
Prospective, single-arm, open-label, US multi-center registry study to evaluate the safety and effectiveness of the 2.25 mm XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.
|
| Sample Size |
150 subjects enrolled at up to 75 sites in the United States
|
| Key Study Endpoints |
The primary endpoint is the composite rate of cardiac death, target vessel myocardial infarction (MI) (per protocol definition), and clinically indicated target lesion revascularization (CI-TLR) at 1 year. This endpoint meets a pre-specified performance goal of 20.4% derived from the 2.25 mm DES data that was obtained in a literature review.
|
| Follow-up Visits and Length of Follow-up |
Clinical F/U: 30 days (clinic visit), 240 days and 1 year (clinic visit), 2, 3 years (clinic or telephone visit).
Angiographic F/U: 240 days (only subjects in the angiographic cohort who received a 2.25 mm XIENCE V EECS are eligible).
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
150
|
| Actual Number of Sites Enrolled |
33
|
| Patient Follow-up Rate |
88.2%
|
| Final Safety Findings |
The overall (0 - 1123 days) definite/probable stent thrombosis rate per ARC was 1.5% (2/130).
|
| Final Effect Findings |
-MACE Rates at 3 years: 12.1% (16/132)
-TVR rates at 3 years: 13.6% (18/132)
-TLF rates at 3 years: 12.1% (16/132)
-Cardiac Death rates at 3 years: 3.8% (5/132)
|
| Study Strengths & 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.
|
| Recommendations for Labeling Changes |
A labeling change is recommended to add a summary of the post-approval study results including study strengths and limitations. The updated label will reflect the long-term performance of the device from the pre-market cohort.
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