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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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Cont f/u of the IDE Study Subjects


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General
Study Status Completed
Application Number /
Requirement Number
P200030 / PAS001
Date Original Protocol Accepted 12/22/2020
Date Current Protocol Accepted  
Study Name Cont f/u of the IDE Study Subjects
Device Name Gore Excluder Conformable AAA Endoprosthesis (CEXC)
Clinical Trial Number(s) NCT02489539 
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 purpose of the post approval study is to evaluate the long-term safety and effectiveness of the Gore Excluder Conformable AAA Endoprosthesis (EXCC). It is a prospective, multi-center, single-arm clinical study. It involves the long-term follow-up of the premarket cohort.
Study Population The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.
Sample Size A total of 80 subjects were enrolled in the study and remaining subjects will be followed.
Key Study Endpoints Serious adverse events, all-cause mortality, aneurysm-related mortality, aneurysm rupture, secondary interventions, conversion to open surgery, losses of device integrity, device occlusions, stenosis or kink, aneurysm enlargement (greater than or equal to 5 mm), stent graft migration (greater than or equal to 10 mm), all types of endoleaks, and other device-related events.
Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years.
Interim or Final Data Summary
Actual Number of Patients Enrolled 80
Actual Number of Sites Enrolled 54
Patient Follow-up Rate Any data | Imaging Data
60 Months: 88.7% (47/53) | 84.9% (45/53)
48 Months: 82.3% (51/62) | 82.3% (51/62)
36 Months: 85.1% (57/67) | 82.1% (55/67)
24 Months: 78.7% (59/75) | 77.3% (58/75)
12 Months: 94.9% (75/79) | 93.7% (74/79)
6 Months: 97.5% (77/79) | 94.9% (75/79)
1 Month: 98.8% (79/80) | 98.8% (79/80)
Final Safety Findings Serious Adverse Events:
• There were two subjects with device-related SAEs.
• There were four subjects with procedure-related SAEs.
All-Cause Mortality:
• There were 15 subjects who experienced this endpoint event.
Aneurysm-Related Mortality:
• No subjects experienced this endpoint event.
Aneurysm Rupture:
• One subject experienced a core lab reported AAA rupture, however, that was not confirmed with assessments from both site and CEC.
Secondary Interventions:
• Nine (11.3%) subjects required reintervention as adjudicated by the CEC. Five of these subjects required reinterventions on more than one occasion.
Conversion to Open Surgery:
• No subjects experienced this endpoint event.
Loss of Device Integrity:
• No subjects experienced this endpoint event.
Device Occlusions:
• No subjects experienced this endpoint event.
Stenosis or Kink:
• No subjects experienced this endpoint event.
Aneurysm Enlargement (greater than or equal to 5 mm):
• Eight (10.3%) subjects experienced this endpoint event as evaluated by core lab.
Stent Graft Migration (greater than or equal to 10 mm):
• No subjects experienced this endpoint event.
All Types of Endoleaks:
• There were no site-reported Type III, Type IV or indeterminate endoleaks. Forty-seven (58.8%) subjects were free from any type of site-reported endoleak. One subject (1.3%) experienced a site-reported Type IA endoleak. Thirty-three subjects (41.3%) experienced a site-reported Type II endoleak. As evaluated by the core lab, there were no subjects with Type I endoleaks, there were 36 subjects (45%) who experienced Type II endoleaks, there were no subjects who experienced Type III or Type IV endoleaks and there were nine subjects (56.3%) who experienced indeterminate endoleaks.
Other Device-Related Events:
• No subjects experienced this endpoint event.
Final Effect Findings N/A
Study Strengths & Weaknesses Strengths: The Short Neck Substudy was successful in meeting its performance goal. The follow-up compliance, including for imaging data, was very high. Follow-up assessments through five years post-procedure have shown continued treatment and device durability. Patients also benefitted from complete freedom from aneurysm-related mortality with reasonable rates of endoleak reintervention and rupture in the total absence of device integrity events. Low rates of long-term device complications, coupled with the immediate benefits of endovascular therapy, confirms the value of CEXC device treatment for AAA.
Weaknesses: The patient population treated was heavily represented by males (88.8%) and Caucasians (93.8%). Female and African American population representation was very low (11.3% and 3.8% respectively). Limited data was available for other races and ethnicities.
Recommendations for Labeling Changes Labeling changes are recommended to present the long-term outcomes of this device.


Cont f/u of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 12/22/2021 12/14/2021 On Time
2 year report 12/22/2022 01/05/2023 Overdue/Received
final report 06/22/2024 06/18/2024 On Time


Contact Us

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

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