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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150002 / PAS001 |
| Date Original Protocol Accepted |
11/27/2018
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| Date Current Protocol Accepted |
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| Study Name |
Long Term INSPIRATION Study
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| Device Name |
INCRAFT(R) AAA STENT GRAFT SYSTEM
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| Clinical Trial Number(s) |
NCT01664078
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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: At least 22 yrs
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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 INCCRAFT AAA 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 190 patients were enrolled.
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| Key Study Endpoints |
The primary endpoint is successful aneurysm treatment through 1 year post-procedure.
Additional endpoints will be collected and reported at each follow-up point through 5 years post procedure (through 10 years for patients with stent fracture(s) identified within the first 5 years), including Major Adverse Events (MAE), aneurysm enlargement (>5mm), aneurysm-related mortality, all types of endoleaks, aneurysm sac rupture, device integrity (e.g. stent strut fracture), device migration (>10 mm), graft occlusion, stenosis or kink, conversion to open surgery and secondary interventions.
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| Follow-up Visits and Length of Follow-up |
Patients will be followed for 5 years. Patients identified with stent fracture(s) within the first 5 years will be followed for an additional 5 years (total 10 years of follow-up).
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
190 subjects. Stent fractures were observed in 20 of the 190 subjects enrolled in the study, with 9 of those subjects being reconsented for an additional 5 years of follow-up.
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| Actual Number of Sites Enrolled |
A total of 32 sites (27 in the U.S. and 5 in Japan) enrolled subjects for the IDE trial. Of these, 7 sites across the U.S. and Japan enrolled subjects with fracture stent fracture for the long- term follow-up study.
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| Patient Follow-up Rate |
Clinical Follow-Up | CT Imaging Follow-Up:
1 Month: 99.5% (189/190) | 98.9% (188/190)
6 Months: 96.8% (182/188) | 94.7% (178/188)
1 Year: 96.7% (177/183) | 95.6% (173/181)
2 Years: 94.1% (162/172) | 91.2% (155/170)
3 Years: 91.9% (148/161) | 89.3% (142/159)
4 Years: 87.1% (129/148) | 79.5% (116/146)
5 Years 93.1% (121/130) | 83.6% (107/128)
6 Years: 87.5% (7/8) | 87.5% (7/8)
7 Years: 87.5% (7/8) | 75% (6/8)
8 Years: 100% (6/6) | 83.3% (5/6)
9 Years: 100% (6/6) | 100% (6/6)
10 Years 100% (5/5) | 100% (5/5)
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| Final Safety Findings |
Major Adverse Events and Procedure-Related Adverse Events:
The overall rate of MAEs is 7.0% at 6 month, 10.9% at 1 year, 18.8% at 2 years, and 22.7% at 3 years, 29.8% at 4 years and 36.4% at 5 years. For the stent fracture subjects followed through 10 years, the overall rate of MAEs is 12.5% at 6 years, 28.6% at 7 years, 42.9% at 8 years, 42.9% at 9 years, and 57.1% at 10 years
Aneurysm-Related Mortality
There has been one (1) ARM in the study (1/190, 0.5%). The subject died of an acute myocardial infarction on post-operative day two.
All-Cause Mortality
Through 10 years, 47 deaths occurred in the study (47/190, 24.7%). Two (2) of these deaths occurred after 5 years (at 7 years and 10 years), Other than the one ARM reported above, all of these deaths were adjudicated as unrelated to the device or procedure per the CEC.
Rupture
There was one (1) incidence of aneurysm sac rupture after completing the 5.5 year follow-up visit (1/190, 0.5%). This subject also experienced a Type Ia endoleak. This required conversion to open repair. This subject underwent an emergency laparotomy and implantation of a bifurcated graft on the same day as the rupture to repair the aneurysm with no major complications.
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| Final Effect Findings |
Stent Fractures
Stent fractures were observed in 20 subjects (20/190, 10.5%) through 5-year follow-up. All fractures were observed in the transrenal stent component (bare stent without graft) and none were located on the fabric-covered stents. Seven (7) subjects were observed with more than one stent fracture, two (2) of whom had multiple fractures observed from the initial imaging and the remaining five (5) of whom had one fracture observed from the initial imaging and additional fractures observed at subsequent follow-up visits.
Aneurysm Sac Expansion (>5 mm)
Through 5 years, there were a total of 31 subjects (31/190, 18.4%) with aneurysm expansion noted. Through 9 year follow-up, 2 more subjects had sac enlargement (> 5 mm). At 10 years, there was 1 subject presenting aneurysm enlargement.
Endoleaks
Through 5 years, there were 18 Type Ia endoleaks in 15 subjects (15/190, 7.9%) and 3 Type Ib endoleaks in 3 subjects (3/190, 1.6%).
There was one Type III endoleak observed at 3 years in 1 subject (1/190, 0.5%). Beyond 5 years, two new subjects reported with type Ia endoleaks: one subject reported type Ia endoleak on 6-year imaging as well as rupture, which required conversion to open repair; one new type Ia endoleak was reported on 8-year imaging, which was treated with chimney stent grafts.
Stent Graft Migration (>10 mm)
Through 10 years post-procedure, there were no subjects observed with bifurcate stent graft migration > 10 mm. However, there are two subjects that each have aortic bifurcate migration of 10 mm noted at the 3-year and 4-year follow up visit. The one subject with migration at the 4-year follow-up visit also experienced a stent fracture. This case was accompanied by aortic neck dilatation but did not require secondary intervention. There was bifurcate stent graft movement > 5 mm observed at 2-, 3-, 4- and 5-years post-procedure in the same subject.
Through 5 years post-procedure, five (5) subjects (5/190, 2.6%) have been observed with proximal iliac limb migration by the Core Lab. Through 10 years post-procedure, limb migration was observed across multiple time points in two (2) subjects with stent fractures. These two incidences of limb migration/movement were cranial in direction and there were no limb separations. There were no secondary interventions performed.
Stent Graft Patency Events (CEC-Adjudicated)
Through 10 years, a total of 11 subjects were reported with 11 stent graft occlusions by the site (11/190, 5.8%); 17 subjects were reported with 19 stent graft stenosis by the site (17/190, 8.9%); only one kink was reported at 3 years (1/190, 0.5%).
Conversions to Open Surgery
There were three (3) conversions to open surgery reported in the study (3/190, 1.6%). One (1) was due to complete occlusion of the aortic bifurcate component. One (1) was due to bilateral iliac limb stenosis. One (1) of the 20 subjects with stent fracture had conversion to open surgery due to rupture and type Ia endoleak (as noted above), which was reported beyond 5 years.
Secondary Interventions
Through 5 years, a total of 35 subjects (35/190, 18.4%) underwent 51 secondary interventions to address endoleaks, vascular injury, procedure complications, device patency and device migration events. Two secondary interventions were necessary beyond 5 years post-procedure in two (2) subjects, one to treat rupture/type Ia endoleak and the other to repair a type Ia endoleak.
Device Malfunctions
Although there were 20 subjects observed with stent fracture, only five (5) of these subjects were determined by investigators as device malfunctions. Three (3) of these five (5) subjects reconsented to the long-term study. There were no other device malfunctions reported.
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| Study Strengths & Weaknesses |
Strengths: This was a prospective, consecutively enrolling, single-arm, multi-center study that consisted of continued follow-up of all available subjects from the INSPIRATION pivotal study. Core Lab analyzed the imaging, and an independent clinical events committee adjudicated event relatedness to the procedure, technique, and/or device. Subjects who experienced stent fractures within the first 5 years of the study were eligible for an additional 5 years of follow-up (total of 10 years of follow-up). There was CEC adjudication involved in the study.
Weaknesses: The study is a non-randomized study with inherent biases. There is limited patient follow-up through 10 years. Only 20 out of the 190 subjects initially enrolled in the study experienced stent fracture. Of those 20 subjects, only 9 subjects were followed after 5 years, with only 5 of those subjects reaching the 10-year time point and 4 subjects exiting the study. Two of the four that exited the study died, while the other two withdrew consent. Of the other 5 subjects, one subject experienced persistent aneurysm enlargement, and the other four subjects did not experience device related effects.
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| Recommendations for Labeling Changes |
A labeling supplement was approved on September 23, 2020 with data out to 5 years. The data through 10 years will not be recommended for a labeling supplement. These results will be available in the latest Clinical Update.
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