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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long Term F/U Study


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General
Study Status Progress Adequate
Application Number P020018 S040/ PAS001
Date Current Protocol Accepted 12/12/2012
Study Name Long Term F/U Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Observational, single-arm, multi-center, prospective cohort study
Study Population Description Subjects from the pivotal trial plus at least 20 new subjects
Sample Size 88
Data Collection Primary endpoint: 5-year aneurysm-related mortality rate;

Secondary endpoints: Aneurysm rupture, conversion to open surgery, device integrity, device patency, change in aneurysm size, endoleak, device migration, secondary interventions, and morbidity index, defined as the percent of patients who have one or more specified adverse events.

Follow-up Visits and Length of Follow-up 5 years

30 days, 1 year, and annually thereafter for 5 years.

Interim or Final Data Summary
Actual Number of Patients Enrolled A total on 88 patients (67 pre-approval patients and 21 post approval patients
Actual Number of Sites Enrolled A total 21 sites were enrolled (15 pre-approval sites and 6 post-approval sites)
Patient Follow-up Rate 94.4% (51/54) and 88.9% (48/54) of patients completed clinical and CT follow -up at 5 years respectively; 63.0% (34/54) of patients had KUB X-ray imaging at 5 years.
Final Safety Findings Aneurysm related mortality rate based on the numerate (n=2 deaths) and a denominator that included patients that had 5-year follow-up visit or death (per approved protocol) is 3.08% (2/65) [Upper confidence limit of 10.68%] compared to PG of 18% (P-value < 0.01).

Kaplan Meier estimates for freedom from aneurysm related mortality using a z statistics was 97.5% [95% CI: 94.0%, 100%] versus PG of 82%. Thus the study met the performance goal.

Tipping Point Analysis

A total of 23 patients had missing 5-year vital status data for the primary endpoint analysis.

Per the sponsor’s tipping point analysis, in addition to the 2 deaths already counted as AAA-related, it would require at least 22% (n=5) of the 23 cases with missing vital status data to also experience AAA-related death for the primary endpoint to fail the hypothesis. This is unlikely given that only 1 treated patient showed aneurysm growth due to Type II endoleak (> 5 mm increase in diameter) at last follow-up which resolved with reintervention while all remaining patients had favorable outcomes i.e., a stable or shrinking aneurysm at last follow-up (1 patient did not receive the study device).
Final Effect Findings The percentage of patients with patency loss based on Core Lab analysis or as reported by site was 0% (0/66) at 2 years, 1.8% (1/56) at 3 years, 0% (0/49) at 4 years and 0% (0/44) at 5 years.

No conversions to open repair were reported through 5 years.

There were 30 secondary interventions in 25 unique patients.

One (1) patient experienced component separation and aneurysm rupture at 5-year time point.

One patient (2.1%, 1/48) experienced Type I distal endoleak at 3 years and one patient (3.0%, 1/33) experienced Type III at 5 years. Type II endoleak rate at 5 years was 9.1% (3/33).

Ten patients experienced aneurysm growth at one or more follow-up time points. At 5 years

72.7% (32/44) of patients had aneurysm shrinkage, 15.9% (7/44) had no change in aneurysm size and 11.4% (5/44) had aneurysm expansion.

Two cases of stent migration involving caudal movement of proximal components occurred in two patients, one at 2 years and the other at 5 years.

Stent graft barb separation and component separation were the most frequently reported device integrity problems 2.2% (1/46) each at 5 years. For fenestration stent, fracture rate and separation rate was 0% (0/44) each at 5 years.
Study Strengths & Weaknesses The study primary endpoint met the performance goal with aneurysm related mortality rate of 2.27% (2/88) compared to PG of 18% (p<0.0001) at 5 years. The impact of missing data on the primary endpoint result was evaluated.

The absolute numbers for patients completing clinical follow-up and imaging assessment at 5 years were low: clinical follow-up (51), CT follow -up (48) and KUB X-ray (34).
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term results of the post approval study. The labeling change should include a new section in the label showing a summary of the post- approval study results (final endpoint results, follow-up rate etc.), strengths and limitations of the PAS.


Long Term F/U Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/03/2012 11/09/2012 Overdue/Received
one year report 04/04/2013 04/04/2013 On Time
18 month report 10/03/2013 10/04/2013 Overdue/Received
two year report 04/04/2014 04/03/2014 On Time
three year report 04/04/2015 04/03/2015 On Time
four year report 04/03/2016 04/04/2016 Overdue/Received
five year report 04/03/2017 04/03/2017 On Time
six year report 04/03/2018 03/23/2018 On Time
seven year report 04/03/2019 04/03/2019 On Time
eight year report 04/03/2020 04/03/2020 On Time
final report 01/31/2021 01/29/2021 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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