|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100040 S036/ PAS001 |
| Date Original Protocol Accepted |
10/19/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued f/u Valiant EVO Study
|
| Device Name |
Valiant Navion Thoracic Stent Graft System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to obtain longer-term follow-up on the use of the Valiant Navion Stent Graft System to treat descending thoracic aortic aneurysms. There will be no new patient enrollment for this study; instead, five-year follow-up will be reported on the surviving patients from the 100 subjects enrolled in the IDE study, in accordance with the IDE protocol.
|
| Study Population |
Patients with descending thoracic aortic lesions who have appropriate anatomy.
|
| Sample Size |
100 patients were enrolled in this IDE. Follow-up data on the surviving patients will be reported in this PAS.
|
| Key Study Endpoints |
Clinical outcomes will include aneurysm-related mortality, aneurysm rupture, aneurysm expansion, Type Ia endoleak, migration, Type III endoleak, re-intervention, device-related adverse events, and device integrity.
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
100 (53 US, 47 OUS)
|
| Actual Number of Sites Enrolled |
33
|
| Patient Follow-up Rate |
Follow-up rate:
1 month: 98/99 (99%)
6 month (required for US only): 56/91 (62%)
1 year: 79/87 (91%)
2 year: 50/52 (96%)
3 year: 46/49 (94%)
4 year: 41/44 (93%)
5 year: 36/38 (95%)
Between the index procedure and the 1-year follow-up visit, 10 subjects died, 2 subjects withdrew, and 1 subject was lost to follow-up.
59 subjects reconsented for 5-year follow-up following completion of the 1-year visit. Between the 1- and 5-year visits, 13 subjects died, 5 subjects withd
|
| Final Safety Findings |
The study used a composite safety and effectiveness endpoint:
Access and/or deployment failures: 0% (0/100)
Major device effects (MDEs) within 30-days of the procedure: 2.0% (2/100)
Device-related secondary procedures: 2.0% (2/100)
Device-related mortality: 1.0% (1/100)
Conversion to open surgery: 0% (0/100)
Thoracic aortic aneurysm rupture: 1.0% (1/100)
30-day secondary endpoints: Perioperative mortality: 2.0% (2/100), Major adverse events: 29.0% (29/100), Serious adverse events: 32.0% (32/100), Secondary procedures: 2.0% (2/100), Loss of stent graft patency: 0.0% (0/95), Endoleaks: 4.3% (4/94)
Secondary endpoints through 5 years:
All-cause mortality: Kaplan-Meier estimate of freedom from all-cause mortality at 1 year: 89.8%, 5 years: 70.9%.
Aneurysm-related mortality: Kaplan-Meier estimate of freedom from aneurysm-related mortality at 1 year: 97.0%, 5 years: 95.1%.
MDEs: Kaplan-Meier estimate of freedom from MDEs at 1 year: 95.8%, 5 years: 22.4%.
Secondary Procedures: Kaplan-Meier estimate of freedom from secondary procedures at 1 year: 0.948%, 5 years: 21.7%.
Endoleaks: 6.4% (5/78) at 1 year, 23.5% (8/34) at 5 years
Stent graft migration: 0.0% (0/79) at 1 year, 5.7% (2/45) at 5 years
Aneurysm expansion: 5.1% (4/78) at 1 year, 14.7% (5/34) at 5 years
Aortic rupture: 1 rupture event at 28 days from the procedure
Loss of device integrity: 11 device integrity events: 3 stent fractures, 2 stent graft ruptures, 2 stent graft fabric defects, 4 stent ring enlargements, 1 stent wire detachment
Loss of stent graft patency: 0.0% at 1 through 5 years
Conversion to open surgery: 0.0% at 1 through 5 years
|
| Study Strengths & Weaknesses |
Study strengths: This study has a high rate of clinical follow-up for eligible subjects through 5 years, collects imaging data for high rate of eligible subjects through 5 years, and includes representation of patients from both North America and Europe.
Study weaknesses: The study is a non-randomized study with inherent biases. There is a low patient sample size reconsented for 5-year follow-up, and the subject race/ethnicity demographics biased toward White patients compared to the total US population
|
| Recommendations for Labeling Changes |
No labeling changes are recommended. The Navion device (commercial version of the Valiant Evo Thoracic Stent Graft) is no longer marketed following voluntary removal of the device from global markets in March 2021.
|
