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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200030 S014/ PAS001 |
| Date Original Protocol Accepted |
04/05/2024
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| Date Current Protocol Accepted |
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| Study Name |
Continued Follow-up of the IDE Study Subjects
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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 |
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 Excluder Conformable AAA Endoprosthesis (EXCC). The study consists of long-term follow-up of the premarket cohort. The study was designed to evaluate the safety and effectiveness of the EXCC device for the treatment of infrarenal AAA including patients with short and/or angulated aortic necks. The pivotal study was comprised of two substudies, the Short Neck (SN) substudy and High Neck Angulation (HNA) substudy. Data from the HNA substudy were the basis for the P200030/S014 approval decision.
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| Study Population |
Patients with abdominal aortic aneurysms having aortic neck angulation up to 90° and infrarenal aortic neck length >10 mm.
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| Sample Size |
A total of 175 subjects were enrolled in the study across the SN and HNA substudies. Ninety-five subjects were enrolled in the HNA substudy and remaining subjects will be followed.
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| Key Study Endpoints |
Major 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 |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Follow-up is not complete and therefore these rates may change as more data becomes available.
Serious Adverse Events: • Device-Related Serious Adverse Events (SAEs): 3 subjects experienced device-related SAEs in the study to date.
• Procedure-Related SAEs: 6/95 subjects (6.3%) experienced procedure-related SAEs in the study to date.
• SAEs (Any): 67/95 subjects (70.5%) experienced an SAE at any time interval to date. All-Cause Mortality:
• 33 subjects experienced all-cause mortality to date. Aneurysm-Related Mortality: • 1/95 subjects (1.1%) experienced aneurysm-related mortality to date. Aneurysm Rupture: • 1/95 subjects (1.1%) experienced an AAA rupture. Secondary Interventions: • 15/95 subjects (15.8%) required reintervention to date, with a total of 27 reinterventions performed. Conversion to Open Surgery: • 4/95 subjects (4.2%) experienced conversion to open repair to date Loss of Device Integrity: • 1 subject experienced lumen obstruction, device compression, and loss of patency. Device Occlusions: • 1 UADE involving device occlusion was reported in the study to date. Stenosis or Kink: • 1 report of stenosis and 1 report of device kinking in the study to date. Aneurysm Enlargement (greater than or equal to 5 mm): • Eighteen (20.5%) 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: • 20/94 subjects (21.3%) had an indeterminate endoleak identified by core lab at any time in the study, with 4 of these subjects undergoing reintervention
• 4 (4.3%) Type I endoleaks were identified by core lab at any time in the study
Effectiveness Results:
Procedural technical success for the HNA substudy was 97.9 % (93/95).
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| Actual Number of Patients Enrolled |
175 (80 in short neck substudy and 95 in high neck substudy)
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| Actual Number of Sites Enrolled |
54
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| Patient Follow-up Rate |
1 Month: 87/95 (91.6%) of eligible subjects had any data; 84/95 (88.4%) had CT imaging data.
6 Months: 83/94 (88.3%) of eligible subjects had any data; 81/94 (86.2%) had CT imaging data.
12 Months: 78/91 (85.7%) of eligible subjects had any data; 78/91 (85.7%) had CT imaging data.
24 Months: 63/82 (76.8%) of eligible subjects had any data; 63/82 (76.8%) had CT imaging data.
36 Months: 55/64 (85.9%) of eligible subjects had any data; 52/64 (81.3%) had CT imaging data.
48 Months: 44/54 (81.5%) of eligible subjects had any data; 41/54 (75.9%) had CT imaging data.
60 Months: 35/44 (79.5%) of eligible subjects had any data; 33/44 (75.0%) had CT imaging data.
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