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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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Cont F/u of the IDE Study Subjects


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General
Study Status Ongoing
Application Number /
Requirement Number
P190015 / PAS001
Date Original Protocol Accepted 05/04/2020
Date Current Protocol Accepted  
Study Name Cont F/u of the IDE Study Subjects
Device Name TREO® Abdominal Stent-Graft System
Clinical Trial Number(s) NCT01328197 NCT02009644 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The purpose of the post approval study is to evaluate the long-term safety and effectiveness of the TREO® Abdominal Stent-Graft System. It is a prospective, multi-center, single-arm clinical study. It involves the long-term follow-up of the premarket cohort.

Study Population The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.

Sample Size A total of 158 subjects were enrolled in IDE Pivotal and Continued Access studies.

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 (> 5 mm), stent graft migration (> 10 mm), all types of endoleaks, and other device-related events.

Follow-up Visits and Length of Follow-up Subjects will be followed for 5 years, with the exception of subjects identified with fracture(s) within the first 5 years who will be offered follow-up for an additional 5 years (total of 10 years of follow-up).

Interim or Final Data Summary
Interim Results Safety Results:
Primary safety:
Composite MAE* rate at 30 days: 0.7% (1/150)
*Composite major adverse events: all-cause mortality, myocardial infarction, stroke, renal failure requiring renal replacement therapy, respiratory failure, paraplegia, bowel ischemia, procedural blood loss =1000cc
Secondary safety:
30 days | 6 months | 1 years
Death: 0% (0/150) | 1.3% (2/150) | 1.4% (2/148)
Stroke: 0% (0/150) | 1.3% (2/150) | 0.7% (1/148)
MI: 0.7% (1/150) | 0% (0/150) | 1.4% (2/148)
Bowel ischemia: 0% (0/150) | 0.7% (1/150) | 0% (0/148)
Respiratory failure: 0% (0/150) | 0% (0/150) | 0.7% (1/148)
Procedural blood loss: 0% (0/150) | 0% (0/150) | 0% (0/148)
Paraplegia: 0% (0/150) | 0% (0/150) | 0% (0/148)
Renal Failure: 0% (0/150) | 0% (0/150) | 0% (0/148)
Composite MAE* rate
6 months: 2.7% (4/150)
1 year: 2.7% (4/148)
2 years: 6.4% (9/148)
3 years: 5.7% (7/128)
4 years: 5.0% (6/119)
5 years: 9.5% (10/105)

Effectiveness Results:
Primary effectiveness:
Treatment success* at 12 months: 93.2% (123/132)
*Composite of technical success (At conclusion of index procedure, graft is patent with absence of Type I/III endoleak or aneurysm rupture), absence of aneurysm enlargement >5mm, stent-graft migration >10mm, absence of fracture conversion, rupture, Type I/III endoleak, or stent-graft occlusion
Secondary effectiveness:
Technical success through 30 days: 98.1% (144/147)
- Endograft occlusion through 30 days: 1.3% (2/150)
- Type I or III endoleak through 30 days: 0.7% (1/147)
Aneurysm rupture: none
Conversion to open surgery: 0 at all timepoints
Stent graft migration: 1.3% (1/79) at 4 years, 0 at all other timepoints
Aneurysm size change (1 year | 3 years | 5 years):
No change: 53.7% (73/136) | 39.2% (40/102) | 30.0% (21/70)
Decrease: 46.3% (63/136) | 55.9% (57/102) | 61.4% (43/70)
Increase (total): 0% (0/136) | 4.9% (5/102) | 8.6% (6/70)
Endoleaks, new and persistent (Type Ia | Type Ib | Type III)
30 days: 0.7% (1/147) | 0% | 0%
6 months: 1.5% (2/134) | 0.7% (1/134) | 0%
1 year: 0.8% (1/133) | 0% | 0%
2 years: 0.9% (1/113) | 0% | 0%
3 years: 1.0% (1/100) | 0% | 0%
4 years: 1.3% (1/79) | 0% | 0%
5 years: 1.5% (1/67) | 0% | 0%
Device integrity incidence (Strut fracture | Barb fracture)
Cumulative # of patients with event at 5 years: 10 | 4
Cumulative # of events at 5 years: 14 | 4
Stent-graft patency (# new occlusions)
30 days: 2
6 months: 1
All other timepoints: 0
Secondary interventions (number of interventions | subjects with any intervention)
30 days: 8 | 4.7% (7/150)
6 months: 4 | 2.0% (3/149)
1 year: 1 | 0.7% (1/144)
2 years: 3 | 2.3% (3/131)
3 years: 3 | 1.7% (2/119)
4 years: 1 | 0.9% (1/111)
5 years: 1 | 1.1% (1/92)
Actual Number of Patients Enrolled Pivotal cohort: 150 subjects
Continued access cohort: 8 subjects (not reported below)
Actual Number of Sites Enrolled 29 sites enrolled at least one subject
Patient Follow-up Rate Clinical follow-up | Imaging follow-up of any modality
1 month: 100% (150/150) | 100% (150/150)
6 months: 93.3% (139/149) | 93.3% (139/149)
1 year: 95.1% (137/144) | 95.1% (137/144)
2 years: 90.8% (119/131) | 90.8% (119/131)
3 years: 90.8% (108/119) | 95.7% (102/119)
4 years: 86.5% (96/111) | 75.7% (84/111)
5 years: 90.2% (83/92) | 77.2% (71/92)
Throughout the study, 11 subjects were lost to follow-up, 25 subjects died, and 31 subjects withdrew early.
Study Strengths & Weaknesses Strengths: This was a prospective, consecutively enrolling study. Imaging was analyzed by a Core Lab, and a Clinical Events Committee adjudicated procedure- and device-relatedness of events. Clinical and imaging follow-up compliance were high (>86% and >75% respectively at all timepoints).
Weaknesses: The study is a non-randomized study with inherent biases. The patient population enrolled was heavily represented by white (98.0%) and male (88.0%) subjects. Limited data is available for other populations.


Cont F/u of the IDE Study Subjects Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
interim report 05/03/2021 05/03/2021 On Time
1 year report 05/04/2021 05/03/2021 On Time
2 year report 05/04/2022 05/04/2022 On Time
3 year report 07/14/2023 07/14/2023 On Time
4 year report 05/03/2024 05/03/2024 On Time
interim report 08/20/2024 08/20/2024 On Time
5 year report 08/20/2025    
final report 08/20/2026    


Contact Us

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

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