f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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SPIRIT XLV PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P110019 S118/ PAS001
Date Original Protocol Accepted 05/06/2022
Date Current Protocol Accepted  
Study Name SPIRIT XLV PAS
Device Name XIENCE Skypoint Everolimus Eluting Coronary Stent System
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


SPIRIT XLV PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/09/2022 09/08/2022 On Time
1 year report 03/11/2023    
18 month report 09/09/2023    
2 year report 03/10/2024    
3 year report 03/10/2025    
4 year report 03/10/2026    
5 year report 03/10/2027    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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