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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P120006 S031/ PAS001 |
| Date Original Protocol Accepted |
06/16/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
Case Selection and Sizing Study
|
| Device Name |
Alto Abdominal Stent Graft System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the post approval study is to compare Endologix Imaging Service’s assessment of the suitability for implantation and device sizing recommendations for the Alto Abdominal Stent Graft System (Alto Device) to the suitability assessment and device sizing recommendations for patients' physicians have selected as suitable to receive the Alto device. It is a prospective, consecutively enrolling, multi-center, single-arm clinical study.
|
| Study Population |
The study population is patients with an infrarenal abdominal aortic aneurysm who a treating physician has determined meet the anatomic criteria for implantation with the Alto device as specified in the approved labeling.
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| Sample Size |
100 commercial subjects enrolled consecutively at each study site and who receive an implantation recommendation for the Alto device from the treating physician.
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| Key Study Endpoints |
Physician’s assessments of patients they select to receive the Alto device will be compared to Endologix Imaging Service’s assessment of these patients on the following:
• Key anatomic sizing measurements (e.g., aortic diameter, aneurysm neck length, aneurysm neck angulation)
• General suitability for endovascular aneurysm repair (EVAR)
• Compliance with the Alto anatomic Indications for Use and a recommendation for implantation with the Alto device
• The Alto Aortic Body size appropriate for treatment.
All product complaints occurring in subjects within 30 days of an Alto implantation procedure will be captured through the Endologix quality system and reported.
|
| Follow-up Visits and Length of Follow-up |
While follow-up visits will not be conducted for this study, any complaint data received for subjects in the study through 30 days after attempted implantation will be reported.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
100
|
| Actual Number of Sites Enrolled |
26
|
| Patient Follow-up Rate |
100%
|
| Final Safety Findings |
Physician user measurement data compared to Endologix Imaging Services shows substantial agreement in anatomical measurements for all vascular characteristics. The overall results show no more than a few millimeters variance in any direction across all anatomical measurements captured. Both the site and Endologix Imaging Services aligned 100% on all Aortic Body recommendations. The patient population receiving the first commercial implants of the Alto device is consistent with the patient population enrolled in the ELEVATE pivotal study and are found to have met the anatomic criteria for device implantation as specified in the approved labeling for the Alto Abdominal Stent Graft System.
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| Final Effect Findings |
n/a
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| Study Strengths & Weaknesses |
n/a
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| Recommendations for Labeling Changes |
Endologix acknowledges FDA’s position that a labeling update is not needed at this time, but agrees to revise the labeling if we identify any data in the PAS study that would warrant a revision.
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