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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P190015 / PAS002 |
| Date Original Protocol Accepted |
07/31/2020
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| Date Current Protocol Accepted |
10/30/2020
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| Study Name |
TREO Post Approval Study
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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 |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The TREO Post Approval Study is a multi-center, open label, single arm, prospective post approval study. The objective of the study is to collect real world safety and effectiveness outcomes of the TREO Abdominal Stent-Graft System in an all-comers population eligible for the endovascular treatment of AAA in routine clinical practice, with emphasis on subjects that experience a device stent-strut or barb fracture.
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| Study Population |
All-comers population
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| Sample Size |
A minimum of 300 subjects will be enrolled.
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| Key Study Endpoints |
The primary endpoints are stent fracture, barb separation, and secondary intervention for adverse events related to stent fracture or barb separation.
Additional endpoints will be collected and reported at each follow-up point through 5 years post procedure, including but not limited to the following: technical success, 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 |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Note that data is reflective of the most recent interim report inclusive of events at all available follow-up timepoints.
All-Cause Mortality*
27 deaths reported
Aneurysm-Related Mortality*
0 events reported
Rupture*
0 events reported
*Through 3-year follow-up available to date.
Effectiveness Results:
Note that data is reflective of the most recent interim report. Subjects are still in follow-up and data will be updated as longer-term follow-up is available.
Aneurysm Enlargement >5 mm**
1 Year: 3.5% (8/226)
2 Year 5.6% (4/72)
3 Year: 0.0% (0/2)
Type I | Type III Endoleak**
30 Day: 1.3% (4/305) | 0.7% (2/305)
1 Year: 0.0% (0/222) | 0.0% (0/222)
2 Year: 1.6% (1/64) | 0.0% (0/64)
3 Year: 0.0% (0/2) | 0.0% (0/2)
Stent-Graft Migration > 10mm**
0 events reported
Stent-strut Fracture**
30 Day: 0.0% (0/259)
1 Year: 1.5% (3/195)
2 Year: 1.5% (1/65)
3 Year: 0.0% (0/2)
Stent-graft Occlusion**
30 Day: 2.3% (7/308)
1 Year: 3.6% (8/224)
2 Year: 1.6% (1/64)
3 Year: 0.0% (0/2)
**Denominator is # of subjects with adequate imaging to assess the event in the given time window.
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| Actual Number of Patients Enrolled |
338 Subjects
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| Actual Number of Sites Enrolled |
41/52 sites enrolled subjects
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| Patient Follow-up Rate |
Note that data is reflective of the most recent interim report (data cut of March 13, 2024). Subjects are still in follow-up and data will be updated as longer-term follow-up is available.
Clinical Visit Performed | CT Imaging Data*
30 Day: 95.0% (321/338) | 93.2% (315/338)
1 Year: 74.4% (241/324) | 71.6% (232/324)
2 Year: 36.2% (84/232) | 31.0% (72/232)
3 Year: 7.3% (4/55) | 3.6% (2/55)
*Many subjects are still within the follow-up windows for 1-year and beyond.
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