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table 5. 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 6. aneurysm size
Measurement
Dome width (mm)
Neck length (mm)
Dome to neck ratio
Parent vessel pre-aneurysm (mm)
Parent vessel post-aneurysm (mm)
Parent vessel caliber 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.
n
%
7
24%
7
24%
5
17%
2
7%
2
7%
1
3%
1
3%
1
3%
1
3%
1
3%
1
3%
1
3%
n
Mean
sD
Min
Max
30
7.4
4.3
2.1
20
30
4.9
1.8
2.1
11
30
1.5
0.5
0.8
2.7
30
3.6
0.6
2.4
4.8
30
3.2
0.7
1.7
4.4
30
1.0
1.0
0.3
1.7
Adverse events were presented in Tables 3 and 4 in the Adverse Events section
above.
Table 7 below summarizes the patient rates with regard to technical feasibility.
table 7. technical Feasibility
technical Feasibility
Ability to access aneurysm
Ability to place stent across aneurysm neck
Two patients could not be accessed based on anatomy.
1
One patient required a secondary endovascular procedure to place a second stent in the correct location
2
because the original stent was inadvertently not deployed at aneurysm site.
3
There were 2 intraoperative device malfunctions involving the markerband of the 2F 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 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, the 2F Stabilizer Catheter was outside the patient at the time of the device
malfunction. Stryker Neurovascular has since increased its markerband bond strength.
Table 8 below summarizes the patient rates with regard to clinical outcome.
table 8. Clinical outcome
outcome
1
% occlusion at discharge
:
2
100%
95-99%
% occlusion at 6 months:
100%
95-99%
The "n" reflects the number of occurrences. The % is based on 29 patients at discharge and 26 patients at
1
6 months.
2
One patient had 2 aneurysms, each with different resulting % occlusion. Therefore, this patient is reported
twice.
other clinical outcomes included:
• No stent stenosis or migration.
• No embolic 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.
ConCoMItant MeDICaL tHerapY
Typical antiplatelet and anticoagulation regimen used for interventional
intracranial procedure is recommended at the discretion of the treating physician.
Do not use the Neuroform Atlas™ Stent System in patients in whom antiplatelet
and/or anticoagulation therapy is contraindicated.
5
n (%)
29/31 (93.5%) patients
1
29/29 (100%) patients
2,3
n (%)
17 (58.6%)
13 (44.8%)
18 (69.2%)
8 (30.8%)
Black (K) ∆E ≤5.0
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