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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P110019 S118/ PAS001 |
| Date Original Protocol Accepted |
05/06/2022
|
| Date Current Protocol Accepted |
07/20/2023
|
| Study Name |
SPIRIT XLV PAS
|
| Device Name |
XIENCE Skypoint Everolimus Eluting Coronary Stent System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The XIENCE Skypoint Large Vessel PAS, SPIRIT XLV, is a prospective, single arm, open-label, multi-center global clinical study to evaluate the continued safety and effectiveness of the XIENCE Skypoint large vessel coronary stent system. This study will require new enrollment.
|
| Study Population |
The device group patients will be implanted with the XIENCE Skypoint LV stent system. There is no control group.
|
| Sample Size |
100 patients, 30 sites in the US or OUS
|
| Key Study Endpoints |
Main 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)
For the assessment of periprocedural MI, modified Academic Research Consortium (ARC) II
definition will be used. In the case when both cardiac Troponin and creatine kinase-MB (CK-MB) are available, cardiac Troponin will be used for the primary cardiac biomarker for MI assessment. For the assessment of spontaneous MI, the 4th universal MI definition will be used.
Secondary Endpoint
1. Target lesion failure (TLFsp-MI) at 1 year
TLFsp-MI is defined as the composite of CD, TV-MI including spontaneous MI and excluding
periprocedural MI and, or ID-TLR
In the case when both cardiac Troponin and CK-MB are available, cardiac Troponin will be used for the primary cardiac biomarker for MI assessment. For the assessment of spontaneous MI, the 4th universal MI definition will be used.
2. Target Lesion Failure (TLFSCAI) at 1 year
TLFSCAI is defined as the composite of CD, TV- MI including both periprocedural MI and spontaneous MI, or ID-TLR
For the assessment of periprocedural MI, Society for Cardiovascular Angiography and Intervention
(SCAI) definition8 will be used. In the case when both cardiac Troponin and creatine kinase-MB (CKMB) are available, cardiac Troponin will be used for the primary cardiac biomarker for MI
assessment. For the assessment of spontaneous MI, the 4th universal MI definition will be used.
|
| Follow-up Visits and Length of Follow-up |
3 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
78
|
| Actual Number of Sites Enrolled |
17
|
| Patient Follow-up Rate |
Follow-up rate is not applicable at this point in the study as patient enrollment for the study has not been completed.
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