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Table 6. aneurysm Location
Location
Carotid ophthalmic
Posterior communicating artery
Carotid cavernous
Anterior choroidal
Basilar tip
Carotid bifurcation
Middle cerebral artery
Anterior cerebral artery
Vertebral artery
Posterior inferior cerebellar artery
Basilar trunk
Other
Table 7. aneurysm Size
Measurement
n
Mean
SD
Dome width (mm)
30
7.4
4.3
Neck length (mm)
30
4.9
1.8
Dome to neck ratio
30
1.5
0.5
Parent vessel
30
3.6
0.6
pre-aneurysm (mm)
Parent vessel
30
3.2
0.7
post-aneurysm (mm)
Parent vessel caliber
30
1.0
1.0
differential (mm)
The 29 patients were implanted with 39 stents to treat their
30 aneurysms. Twenty (69%) patients had 1 stent, 8 (28%)
patients had 2 stents, and 1 (3%) patient had 3 stents. The stents
implanted ranged from 3.5 mm to 4.5 mm. One patient required a
secondary endovascular procedure to place a second stent in
the correct location because the original stent was inadvertently
not deployed at aneurysm site; this counts for 2 of the stents.
One patient had the original stent successfully deployed but was
removed during the embolic coiling procedure when the clinical
study investigator attempted to snare the errant coil loop and
dislodged the stent. A replacement stent was implanted in its
place, and this counts for 2 of the stents. For 7 patients, multiple
stents were used to treat one aneurysm in cases where (1) the
embolic coiling procedure left the tail of an embolic coil in the
vessel or (2) the neck of aneurysm was estimated at an incorrect
width and a second or third stent was necessary to cover the
neck of the aneurysm.
With regard to patient accounting, 31 patients were originally
entered into the study; however, 2 did not receive the stent. One
patient died immediately after the procedure. There are adverse
event data on 29 patients, including the one death. Therefore,
there were 28 patients of 31 who were expected for evaluation
through 6 months. At discharge, 28 of the expected 28 were
evaluated for a follow-up rate of 100%. At 6 months, 26 of 28
patients were evaluated for a follow-up rate of 93%.
The study endpoints were (1) adverse events, (2) technical
feasibility, and (3) clinical outcome. The incidence of all
adverse events, device or procedure-related, were assessed.
Technical feasibility was assessed by the ability to access the
aneurysm and place the stent accurately across the aneurysm
neck. Clinical outcome was assessed by percent angiographic
aneurysm occlusion.
Adverse events were presented in Tables 2 and 3 in the Adverse
Events section above.
Table 8 below summarizes the patient rates with regard to technical
feasibility.
n
%
Table 8. Technical Feasibility
7
24%
Technical Feasibility
7
24%
Ability to access aneurysm
5
17%
Ability to place stent across
2
7%
aneurysm neck
2
7%
1
Two patients could not be accessed based on anatomy.
2
One patient required a secondary endovascular procedure to place a second stent in the
1
3%
correct location because the original stent was inadvertently not deployed at aneurysm site.
There were 2 intraoperative device malfunctions involving the markerband of the 2F
3
1
3%
Stabilizer Catheter inadvertently detaching from the shaft of the 2F Stabilizer Catheter after
stent deployment. In one patient, the 2F Stabilizer Catheter was inside the patient at the
1
3%
time of the device malfunction, and the separated markerband embolized in a small, distal
intracranial artery. This patient had no adverse events from this event. In the second patient,
1
3%
the 2F Stabilizer Catheter was outside the patient at the time of the device malfunction.
Stryker Neurovascular has since increased its markerband bond strength.
1
3%
Table 9 below summarizes the patient rates with regard to clinical
outcome.
1
3%
Table 9. Clinical Outcome
1
3%
Clinical Outcome
1
% occlusion at discharge
Min
Max
100%
2.1
20.0
95-99%
2.1
11.0
% occlusion at 6 months
0.8
2.7
100%
2.4
4.8
95-99%
1.7
4.4
The "n" reflects the number of occurrences. The % is based on 29 patients at discharge and
1
26 patients at 6 months.
One patient had 2 aneurysms, each with different resulting % occlusion. Therefore, this
2
patient is reported twice.
0.3
1.7
Other clinical outcomes included:
• No stent stenosis or migration.
• No emboli coil migration.
• No parent vessel thrombosis, occlusion, or dissection.
• Neurological status: Of 26 patients evaluated at 6 months,
17 (65%) had an unchanged (normal) neurological assessment as
compared to baseline, 3 (16%) had an improved (from abnormal
to normal) neurological assessment as compared to baseline,
5 (19%) had an unchanged (abnormal) neurological assessment
as compared to baseline, and 1 (4%) had a worsened (abnormal
moderate confusion to abnormal severe confusion) neurological
assessment as compared to baseline.
A clinical study was conducted in Japan to evaluate the safety
and effectiveness of the Neuroform EZ™ Stent System. The patient
inclusion criteria were: (1) wide neck, unruptured intracranial
aneurysm 10 mm or larger at the largest point that is not amenable
to surgery or coil embolization alone, where a wide neck is defined
as a neck diameter of ≥ 4 mm or a dome-to-neck ratio < 2; (2)
aneurysm is in an artery with a diameter of 2.0 to 4.5 mm; (3) patient
is between 20 and 80 years of age at the time of consent.
The primary endpoint was procedure success defined as meeting
all of the following conditions: (1) Ability to place the Neuroform
stent at the neck of the cerebral aneurysm; (2) Ability to complete
the aneurysm coil embolization and retain the coil mass within
the aneurysm at end of procedure; (3) No Major Adverse
Cerebrovascular Event (MACVE) related to the device or procedure
within 30 days after the procedure.
Patients were assessed clinically at Baseline and at 7 days, 30 days,
and 6 months after the procedure. Angiographic evaluation was
conducted at Baseline, Procedure and 6 months after the procedure.
An independent Data Monitor evaluated safety data. An independent
review of angiographic imaging was conducted by an Image
Review Board to assess the status of stent placement and coil mass
retention and Independent review of clinical events was conducted
to determine whether they met the definition of MACVE and to assess
the relationship between the event and the device or procedure.
A total of 20 subjects with 20 aneurysms were enrolled at two sites.
The average age was 59.3±10.6 years and 14 of 20 (70%) were female.
All patients underwent stent placement and coil embolization.
Table 10 summarizes the locations of the 20 aneurysms. Table 11
summarizes sizes of the 20 aneurysms.
n (%)
29/31 (93.5%) patients
1
29/29 (100%) patients
2,3
n (%)
2
17 (58.6%)
13 (44.8%)
18 (69.2%)
8 (30.8%)
®
3
Table 10. aneurysm Location
Location
Paraclinoid segment of the carotid artery
Carotid cavernous sinus
Vertebral artery
Posterior communicating artery
Basilar trunk
Petrous segment of the carotid artery
Table 11. aneurysm Size
Measurement
n
Mean
SD
Min
Parent artery
diameter:
20
3.73
0.66
proximal (mm)
Parent artery
diameter:
20
3.31
0.54
distal (mm)
Max. dome
20
12.24
3.34
diameter (mm)
Neck
20
6.92
3.49
diameter (mm)
Dome-to-neck
20
1.94
0.60
ratio
All 20 subjects underwent stent placement and coil embolization.
Three subjects required placement of 2 stents resulting in a
total of 23 stents implanted. In two cases a second stent was
placed due to improper location of the first stent and in one
case the tip of the coil protruded into the parent artery. In all
cases satisfactory neck coverage was achieved at the end of
the procedure and these procedures were determined to meet
criteria for procedure success by the Image Review Board. Coil
embolization was performed in all cases and the coil mass was
retained within the aneurysms at the end of the procedure. No
incidence of MACVE was observed in any case during the study.
Thus, all subjects were rated as a "procedure success" and met
the primary endpoint. Data is available for 20 patients at 30 days
and 19 patients at 6 months (one patient withdrew consent).
Adverse events are presented in Tables 4 and 5. A summary of
procedure outcome is provided in Table 12.
Table 12. Summary of Procedure Outcome
Procedure Outcome
30 days
n
%
Procedure Success
20
100.0%
1
Successful stent
20
100.0%
placement
2
Successful coil
20
100.0%
embolization
2
Successful retention
20
100.0%
of coil mass
2
95% confidence interval: 83.2% - 100.0%
1
Data based on Image Review Board assessment.
2
One patient withdrew consent after 30 days
3
Cranial nerve and general neurological status evaluations
were conducted and included assessment of NIH Stroke
Scale (NIHSS), Barthel and modified Rankin (mRS) scores. No
significant changes in neurological or cranial nerve function
were reported. Table 13 summarizes neurological status
evaluations.
n
%
11
55.0%
3
15.0%
3
15.0%
1
5.0%
1
5.0%
1
5.0%
Med Max
2.5
3.70
4.9
2.1
3.35
4.2
8.0
11.05
20
3.2
6.40
20
1.0
1.80
3.3
6 months
n
%
-
-
19
95%
3
-
-
19
95%
3
Black (K) ∆E ≤5.0
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