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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P200030 / PAS001 |
| Date Original Protocol Accepted |
12/22/2020
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| Date Current Protocol Accepted |
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| Study Name |
Cont f/u of the IDE Study Subjects
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| Device Name |
Gore Excluder Conformable AAA Endoprosthesis (CEXC)
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| Clinical Trial Number(s) |
NCT02489539
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| 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.
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| Study Population |
The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.
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| Sample Size |
A total of 80 subjects were enrolled in the study and remaining subjects will be followed.
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| 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.
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for 5 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
80
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| Actual Number of Sites Enrolled |
54
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| 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)
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| 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.
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| Final Effect Findings |
N/A
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| 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.
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| Recommendations for Labeling Changes |
Labeling changes are recommended to present the long-term outcomes of this device.
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