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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P190015 / PAS001 |
Date Original Protocol Accepted |
05/04/2020
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Date Current Protocol Accepted |
 
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Study Name |
Cont F/u of the IDE Study Subjects
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Device Name |
TREO® Abdominal Stent-Graft System
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Clinical Trial Number(s) |
NCT01328197 NCT02009644
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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 |
Adult: >21
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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.
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Study Population |
The study population is patients with an infrarenal abdominal aortic aneurysm who met the study selection criteria.
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Sample Size |
A total of 158 subjects were enrolled in IDE Pivotal and Continued Access studies.
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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.
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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).
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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)
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Actual Number of Patients Enrolled |
Pivotal cohort: 150 subjects Continued access cohort: 8 subjects (not reported below)
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Actual Number of Sites Enrolled |
29 sites enrolled at least one subject
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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.
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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.
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