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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200030 S014/ PAS002 |
| Date Original Protocol Accepted |
12/04/2024
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| Date Current Protocol Accepted |
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| Study Name |
Post Approval Surveillance - LEAF
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| Device Name |
GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)
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| Clinical Trial Number(s) |
NCT02489539
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Primary Data Set: The Long-term EVAR Assessment and Follow-up (LEAF) System is a post-market, observational surveillance effort utilizing an enhanced registry framework and claims-based linkages with targeted clinical and imaging follow-up. The objective of this system is enhanced surveillance of long-term real-world EVAR device outcomes through ten years after implantation.
Supplemental Data Set: The TOGETHER Registry is a prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for subjects treated with the EXCC device or the EXCLUDER Iliac Branch Endoprosthesis (IBE device) as a part of routine clinical practice.
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| Study Population |
The LEAF surveillance population will consist of primarily Medicare patients who have undergone or will undergo EVAR at hospitals participating in the SVS-VQI, or patients who have undergone or will undergo EVAR at hospitals in the KP network.
The TOGETHER registry will consist of patients presenting with vascular disease who are treated with the applicable endovascular stent grafts.
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| Sample Size |
A minimum of 125 subjects with evaluable imaging at 5 years to support imaging endpoint analysis.
Note: No minimum sample size from the Together Registry is required per protocol. Data from the Together Registry is intended to provide supplemental information on subjects from this dataset to support data collection from LEAF Registry.
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| Key Study Endpoints |
LEAF:
Clinical endpoints will include the following:
• Mortality
• Aneurysm-related mortality
• Rupture
• Reintervention (reason and type)
• Conversion to open surgery
Imaging endpoints will include the following:
• Change in aneurysm size
• Endoleak (by type)
• Device patency
TOGETHER: Gore will summarize Together data with consistent endpoint and definitions as LEAF (summarized above) for both specified subgroups and Together cohort as a whole. Specific sub-group reporting requirements will be addressed with Together until LEAF sub-group reporting is available.
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| Follow-up Visits and Length of Follow-up |
Follow-up to be completed per each participating site’s standard of care (SOC) for 10 years (120 months) post-procedure.
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