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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140016 / PAS001 |
| Study Name |
Post-Approval Study
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| Device Name |
ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT
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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 |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Objective:
To monitor longer-term (5 year) safety and effectiveness of the device.
Design: Prospective, nonrandomized, single-arm, multicenter, multinational study. This is a continued follow-up of premarket cohorts, including pivotal study and continued access cohorts in accordance with the previously approved Investigational Device Exemption protocol.
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| Study Population |
Subjects who are enrolled in the aneurysm/ulcer clinical study initiated prior to device approval and alive at the time of the device approval.
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| Sample Size |
The total patients who are alive at the time of device approval
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| Key Study Endpoints |
Primary safety endpoints:
The 30 day freedom from major adverse event (MAE) rate
Primary effectiveness endpoints:
The 12-month device success rate.
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| Follow-up Visits and Length of Follow-up |
5 years
post-procedure (pre-discharge), 30 days, 6 months, 12 months, yearly thereafter through 5 years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
A total of 110 patients were enrolled in the pivotal study and 18 patients in the Continued Access cohort.
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| Actual Number of Sites Enrolled |
Twenty-three (23) sites including 14 sites in the U.S. and 9 sites outside of the United States.
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| Patient Follow-up Rate |
Pivotal cohort, clinical Follow-up was 90.5% (57/63) at 5 years; CT scan was completed for 85.7% (54/63) of patients at 5 years.
Continued Access cohort, clinical follow-up was 77.8% (7/9) at 5 years, CT scan was completed for 77.8% (7/9) of patients at 5 years.
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| Final Safety Findings |
Aneurysm related Mortality
Survival from aneurysm-related mortality by Kaplan Meier (KM) estimate at 5 years in the pivotal cohort was 99% for all patients, 98.8% for the aneurysm group and 100% for the ulcer group. Through 5 years there was one (1) CEC confirmed aneurysm-related death in the pivotal cohort, and two confirmed aneurysm related death in the continued access cohort.
All-Cause Mortality
Survival from all-cause mortality by KM estimate at 5 years for pivotal cohort was 75.9% for all patients. There were a total 23 deaths in the pivotal cohort and 10 deaths in the continued access cohort.
Endoleak
For pivotal cohort, there were 13 patients with Type I endoleak, 16 patients with Type II endoleak, 2 patients with Type III endoleak and 6 patients with unknown endoleak type. cohort. At 5 years, the percentage of pivotal patients with Type I endoleak was 13.6% (6/44), Type II endoleak rate was 6.8% (3/44), Type III endoleak rate was 0%.
For continued access patients, there were 8 patients with core laboratory reported endoleak.
Change in Aneurysm Size
In the pivotal cohort, a total of 20 patients experienced aneurysm growth at one or more follow-up timepoints. At 5-year timepoint, the percentage of all patients with an increase (> 5 mm) in aneurysm size was 26.0% (13/50), decrease (> 5 mm) in aneurysm size was 24.0% (12/50) and no change (less than or equal to 5 mm) in aneurysm size was 50%.
In the continued access cohort, core laboratory increases in aneurysm occurred in 5 patients.
Rupture
No rupture was reported for pivotal and continued access patients through 5 years post procedure. Two ruptures were reported for pivotal patients after 5 years.
Graft Patency
No pivotal patients experienced occlusion in the pivotal or continued access cohort.
Device Integrity
The percentage of pivotal patient that experienced at stent fracture at 2, 3, 4 and 5 years for all pivotal patients was 1.3% (1/80), 1.4% (1/72), 1.5% (1/68) and 0%. There were no reports of clinical sequelae from the stent fracture.
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| Final Effect Findings |
(cont)
There was one report of component separation reported by the core-lab in the continued access cohort.
Migration
There were three (3) reports of CEC confirmed migration, 3.8% (3/80) at 2 years in the pivotal patients. The percentage of pivotal patients that experienced stent migration from 3 through 5 years was 0% at each timepoint.
One report of CEC confirmed migration occurred in the continued access cohort at 5 years.
Secondary Intervention
A total of 19 pivotal patients have undergone a secondary intervention. Eleven (11) of the secondary interventions occurred in patients with core-laboratory observed growth of the treated aneurysm.
In total 4 patents in the continued access cohort have required secondary intervention for reasons of Type I and Type III endoleaks, Type I endoleak and device migration, device separation and Type III endoleak, and persistent Type I endoleak.
Conversion
There has been one (1) conversion to open surgical repair in the pivotal cohort which occurred at 1 year. KM estimate of freedom from conversion at 5 years was 99.0%.
There have been no conversions to open repair in the continued access cohort.
Major Adverse events
A total of 46 patients in the pivotal cohort experienced a major adverse events (MAE) through 5 years. KM estimate of freedom from major adverse event at 5 years for all pivotal patients was 53.7%.
There were 13 patients in the continued access cohort with MAEs. The MAEs include wound complication requiring return to operating room (n=1), death (n=6), stroke (n=1), re-intubation (n=1), aneurysm or vessel leak requiring re-operation (n=3), and persistent endoleak (n=1).
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| Study Strengths & Weaknesses |
Study Strength: This study is a multicenter study involving 23 investigational sites, 14 in the US and 9 sites outside of the U.S. Clinical Follow-up and imaging out to 5 years were completed for at least 75 of patients in the pivotal and continued access cohorts.
Weakness: This is a non-randomized study with inherent biases.
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| Recommendations for Labeling Changes |
Labeling update is recommended to reflect the long-term results of the pivotal and continued Access study. The labeling change should include a new section on the label showing a summary of the study results (final endpoint results, clinical follow-up rate and available imaging), strengths and limitations of long-term Study.
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