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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P100021 S063/ PAS001 |
| Date Original Protocol Accepted |
09/29/2017
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| Date Current Protocol Accepted |
05/28/2021
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| Study Name |
Cont f/u ANCHOR Reg Short Neck Cohort
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| Device Name |
Endurant II/IIs Stent Graft System
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| Clinical Trial Number(s) |
NCT01534819
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Historical Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to evaluate the long-term safety and effectiveness outcomes on the use of the Endurant II/IIs Stent Graft System to treat short neck infrarenal abdominal aortic aneurysms when used in conjunction with the Heli-FX EndoAnchor System. The study was originally approved with enrollment of 70 subjects to be followed for up to 5 years. Clinical safety and effectiveness outcomes from the 70 subjects were used to seek an indication expansion for the Endurant II/IIs Stent Graft System to treat short (proximal neck lengths greater than or equal to 4 mm and < 10 mm) neck infrarenal abdominal aortic aneurysms when used in conjunction with the Heli-FX EndoAnchor System. In May 2021, FDA approved a study expansion to include clinical data for 60 additional core lab-verified short neck subjects from the ANCHOR registry to support the long-term safety and effectiveness for the short neck indication. These additional 60 subjects will be followed through 5 years as per the ANCHOR clinical investigation plan requirements.
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| Study Population |
Patients with an abdominal aortic aneurysm with an infrarenal neck length measured as greater than or equal to 4 to <10mm by the core laboratory, who met the selection criteria and who were treated with an Endurant or Endurant II/IIs Stent Graft System and the Heli-FX EndoAnchor System during the initial repair of their aneurysm.
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| Sample Size |
70 patients were enrolled in Short Neck Cohort. Follow-up data on the surviving patients in this cohort will be reported in this PAS.
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| Key Study Endpoints |
Clinical outcomes will include aneurysm-related mortality, aneurysm rupture, aneurysm expansion, Type Ia endoleak, migration, Type III endoleak, re-intervention, device-related adverse events, and device integrity.
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
130 [70 original Short Neck (SN) subjects + 60 supplemental SN ANCHOR Registry subjects]
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| Actual Number of Sites Enrolled |
40 sites (total contributing subjects to either original SN cohort or supplemental ANCHOR registry cohort)
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| Patient Follow-up Rate |
All eligible subjects completed 5 years of follow-up. Of the 33 eligible subjects from the original SN cohort, 28 subjects (85%) completed clinical follow-up and 23 subjects (70%) completed imaging (including CT, DUS, and/or MRA) follow-up. Of the 35 eligible subjects from the supplemental SN ANCHOR Registry cohort, all 35 subjects (100%) completed clinical follow-up and 27 subjects (77%) completed imaging (including CT, DUS, and/or MRA) follow-up.
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| Final Safety Findings |
Safety and Effectiveness Results The summary of results below includes events occurring between day 1 through day 2009 for endoleaks and aneurysm expansion, and events occurring between day 0 through day 1826 for aneurysm-related mortality, reintervention, aneurysm ruptures, migration, device-related adverse events and loss of device integrity.
Aneurysm Related Mortality: Six subjects from the original SN cohort experienced aneurysm related mortality. The rate of freedom from aneurysm related mortality through 5 years in the original SN cohort was 90.1%. One subject from the supplemental SN ANCHOR cohort experienced aneurysm related mortality. The rate of freedom from aneurysm related mortality through 5 years in the supplemental SN ANCHOR cohort was 97.4%
Reintervention: Eleven subjects from the original SN cohort had a total of 16 secondary procedures. Of the 16 procedures, 11 were secondary endovascular procedures, 3 were conversions, and 2 were other open surgical procedures. This cohort experienced a 76.9% rate of freedom from any secondary procedure through 5 years. One additional original SN cohort subject had a secondary endovascular procedure reported after the 5-year cutoff day. Eleven subjects from the supplemental SN ANCHOR cohort had 13 secondary procedures performed. Of the 13 procedures, 11 were secondary endovascular procedures and 2 were other open surgical procedures. The supplemental SN ANCHOR cohort experienced a 75.6% rate of freedom from any secondary procedures through 5 years.
Aneurysm ruptures: Two subjects from the original SN cohort experienced ruptures. This cohort experienced a 95.6% rate of freedom from aneurysm rupture through 5 years. One additional original SN cohort subject experienced a rupture after the 5-year cutoff day. Two subjects from the supplemental SN ANCHOR cohort experienced ruptures. This cohort experienced a 96.6% rate of freedom from ruptures through 5 years.
Aneurysm expansion: Nine subjects from the original SN cohort and eight subjects from the supplemental SN ANCHOR cohort experienced new aneurysm expansion through 5 years.
Migration: None reported in either cohort through 5 years.
Endoleaks: Nine subjects from the original SN cohort experienced 8 Type Ia endoleaks through 5 years. Four subjects from the supplemental SN ANCHOR cohort experienced Type Ia endoleaks through 5 years, including one reported on day 0 post implant. No Type III endoleaks were reported in either cohort through 5 years.
Device Related Adverse Events (AEs): Six subjects from the original SN cohort experienced a total of 10 device-related AEs through 5 years. One additional original SN cohort subject had 2 device-related AEs after the 5-year cutoff day. Seven subjects from the supplemental SN ANCHOR cohort experienced a device-related AE through 5 years.
Loss of Device Integrity: One subject in the original SN cohort experienced an EndoAnchor fracture through 5 years. No losses of device integrity events were reported in the supplemental SN ANCHOR cohort.
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| Study Strengths & Weaknesses |
Strengths: The study SN cohort, which adhered to standard of care for clinical and imaging visits, was prospectively analyzed from the ANCHOR registry, a large, real-world, non-interventional study. No new safety or effectiveness concerns were observed in either real-world cohort over the long-term follow-up period. The outcomes were consistent and similar between the two study cohorts and demonstrated the long-term safety and effectiveness of the device combination and indication (Endurant II/IIs stent graft system in conjunction with the Heli-FX EndoAnchor system) in real-world use.
Weaknesses: Visit windows were not prospectively defined in the ANCHOR protocol, and the timing and method of imaging collection were completed per local institution standard of care. The ANCHOR protocol included recommendations on imaging follow-up per the regional societal guidelines (SVS or ESVS) or local institutional guidelines but did not require investigators to follow specific imaging recommendations or bring subjects in for follow-up at specific timepoints. Overall, at all timepoints, imaging included a mix of CT scans and/or DUS modalities, and imaging visit compliance was lower than clinical visit follow-up compliance. Because imaging modalities such as DUS are not sensitive for detection of all endograft performance events (e.g., migration, stent fracture, fabric tear, etc.), under-reporting of these events may have occurred.
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| Recommendations for Labeling Changes |
yes
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