28
Table 6.4.5 CT Findings – Graft Patency
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
Graft patency
100%
(185/185)
99%
(85/86)
100%
(47/47)
30 day
6 month
99%
(183/184)
100%
(74/74)
100%
(39/39)
12 month
99%
(153/155)
100%
(62/62)
100%
(30/30)
24 month
100%
(96/96)
100%
(33/33)
100%
(25/25)
Table 6.4.6 CT Findings – Graft (Main Body) Migration
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
Graft migration (>5 mm) at 12 months
0.0%
(0/162)
0.0%
(0/71)
0.0%
(0/34)
with clinical sequelae
1
or intervention
without clinical sequelae
1
or intervention
2.5%
(4/162)
2.8%
(2/71)
0.0%
(0/34)
Graft migration (>10 mm)
0.0%
(0/162)
0.0%
(0/71)
0.0%
(0/34)
1
Migration with clinical sequelae would include endoleak, conversion, rupture or AAA-related death.
Table 6.4.7 Abdominal Radiograph Findings – Limb Separation
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
Limb separation
0.0%
(0/176)
0.0%
(0/86)
0.0%
(0/39)
Pre-discharge
30 day
0.0%
(0/178)
0.0%
(0/86)
0.0%
(0/43)
6 month
0.0%
(0/167)
0.0%
(0/80)
0.0%
(0/35)
12 month
0.0%
(0/149)
0.0%
(0/60)
0.0%
(0/28)
24 month
0.0%
(0/93)
0.0%
(0/42)
0.0%
(0/19)
6.5 Endoleak Management
During the clinical study Type I endoleaks were treated during the initial procedure by use of additional balloon seating or if unsuccessful, additional prostheses.
Type II endoleaks were observed for a period of one to six months to determine if they would spontaneously thrombose, or in the absence of enlarging
aneurysms, they were treated with endovascular techniques at the discretion of the practicing physician. If the aneurysm enlarged, treatment by embolization
or ligation was considered and, in some cases, performed. Type III endoleaks caused by graft defects, inadequate seal or disconnection of the modular
components were treated with additional ballooning or prostheses. As reported by the angiographic core lab, there were no Type IV endoleaks during the U.S.
clinical study. The graft material used to manufacture the Zenith AAA Endovascular Graft is of standard thickness and is the same material used in open surgical
procedures. Table 6.5.1 presents the incidence of endoleaks by evaluation interval, as identified by the Core Lab for the standard risk, high risk and roll-in
patients, respectively.
Table 6.5.1 Endoleaks (All Types, New and Persistent)
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
Endoleaks
15%
(23/153)
14%
(11/78)
12%
(3/26)
Pre-discharge
30 day
1
9.9%
(16/161)
12%
(9/75)
6.3%
(2/32)
6 month
1
8.7%
(15/172)
11%
(8/70)
8.6%
(3/35)
12 month
1
7.4%
(11/148)
8.8%
(5/57)
3.4%
(1/29)
1
Includes both persistent endoleaks and new observations.
Tables 6.5.2 – 6.5.4 present the incidence of first occurrence of an endoleak according to evaluation interval, as identified by the Core Lab at or before the
30-day, 6-month and 12-month exams for the standard risk, high risk and roll-in patients, respectively. The number of patients who are leak-free thereafter is also
given.
Table 6.5.2 First Occurrence of Endoleak
1
for Standard Risk Patients
One-Month Exam
N=179
Six-Month Exam
N=172
Twelve-Month Exam
3
N=148
Item
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
Endoleaks
17
31
17
2.3
4
3
3.4
5
2
Proximal Type I
2.8
5
4
0.0
0
0
0.0
0
0
Distal
1.7
3
1
0.0
0
0
0.7
1
1
Type I
Type II
9.5
17
9
2.3
4
3
1.4
2
1
Type III
1.1
2
2
0.0
0
0
0.7
1
0
Type IV
0.0
0
0
0.0
0
0
0.0
0
0
Multiple
1.1
2
1
0.0
0
0
0.0
0
0
Unknown
1.1
2
0
0.0
0
0
0.7
1
0
1
Identified by Core Lab.
2
Subsequent endoleaks may have been of different type than original.
3
Only 2 patients had new endoleaks after 12 months; follow-up after 24 months not available.
Table 6.5.3 First Occurrence of Endoleak
1
for High Risk Patients
One-Month Exam
N=88
Six-Month Exam
N=70
Twelve-Month Exam
3
N=57
Item
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
Endoleaks
18
16
6
2.9
2
0
3.5
2
1
Proximal Type I
2.3
2
1
0.0
0
0
0.0
0
0
Distal
1.1
1
1
0.0
0
0
0.0
0
0
Type I
Type II
9.1
8
3
1.4
1
0
1.8
1
0
Type III
0.0
0
0
1.4
1
0
1.8
1
1
Type IV
0.0
0
0
0.0
0
0
0.0
0
0
Multiple
4.5
4
0
0.0
0
0
0.0
0
0
Unknown
1.1
1
1
0.0
0
0
0.0
0
0
1
Identified by Core Lab.
2
Subsequent endoleaks may have been of different type than original.
3
No endoleaks after 12 months; follow-up after 24 months not available.
Table 6.5.4 First Occurrence of Endoleak
1
for Roll-In Patients
One-Month Exam
N=36
Six-Month Exam
N=35
Twelve-Month Exam
3
N=29
Item
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
%
Endoleak
1
Leak-free
Thereafter
2
Endoleaks
11
4
2
2.9
1
0
0.0
0
0
Proximal Type I
0.0
0
0
0.0
0
0
0.0
0
0
Distal
0.0
0
0
0.0
0
0
0.0
0
0
Type I
Type II
5.6
2
1
2.9
1
0
0.0
0
0
Type III
2.8
1
0
0.0
0
0
0.0
0
0
Type IV
0.0
0
0
0.0
0
0
0.0
0
0
Multiple
0.0
0
0
0.0
0
0
0.0
0
0
Unknown
2.8
1
1
0.0
0
0
0.0
0
0
1
Identified by Core Lab.
2
Subsequent endoleaks may have been of different type than original.
3
No endoleaks after 12 months; follow-up after 24 months not available.
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