Feasibility of Super-Bore 0.088 Mechanical Thrombectomy in M1 Vessels Smaller Than 8 French: Experience in 20 Consecutive Cases

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New Devices and Technology

Interventional Neuroradiology
′′
Feasibility of super-bore 0.088 mechanical 1–7
© The Author(s) 2024

thrombectomy in M1 vessels smaller than Article reuse guidelines:

8 French: Experience in 20 consecutive cases sagepub.com/journals-permissions


DOI: 10.1177/15910199241229198
journals.sagepub.com/home/ine

Jessica K Campos1 , Benjamen M Meyer2 , Muhammad Waqas Khan3,


Fahad J Laghari3, David A Zarrin4, Jonathan Collard de Beaufort5, Gizal Amin3,
Kiarash Golshani1, Matthew T Bender6, Geoffrey P Colby7, Li-Mei Lin3
and Alexander L Coon3

Abstract
Introduction: Superbore 0.088′′ catheters provide a platform for optimizing aspiration efficiency and flow control during
stroke mechanical thrombectomy procedures. New superbore catheters have the distal flexibility necessary to navigate com-
plex neurovascular anatomy while providing the proximal support of traditional 8F catheters. The safety and feasibility of
Zoom 88™ superbore angled-tip catheters in the middle cerebral artery (MCA) segments smaller than the catheter diameter
have not been previously described.
Methods: Twenty consecutive cases of acute MCA mechanical thrombectomy were retrospectively identified from the senior
authors’ prospectively maintained Institutional Review Board-approved database, in which the Zoom 88 (Imperative Care,
Campbell, CA) catheter was successfully navigated to at least the M1 segment. Patient demographics, procedural details,
and periprocedural information were analyzed. Rates and averages (standard errors) are generally reported.
Results: The average National Institutes of Health Stroke Scale at presentation and age were 15 ± 2 and 73 ± 3 years, respect-
ively. The M1 and M2 occlusions were evenly distributed. The average M1 measurements before thrombectomy ranged from
2.36 ± 0.07 mm proximally to 2.00 ± 0.11 mm distally, and after thrombectomy, they ranged from 2.34 ± 0.07 mm proximally
to 1.97 ± 0.10 mm distally. First-pass modified thrombolysis in cerebral infarction (mTICI) 2C/3 recanalization was achieved in
40% of cases, and final mTICI 2C/3 recanalization was achieved in 90% of cases. A single case of mild vasospasm was man-
aged with verapamil. No hemorrhagic or periprocedural complications were noted.
Conclusion: Superbore 0.088′′ catheters with flexible distal segments can be safely navigated to the MCA to augment mech-
anical thrombectomy even when the MCA segment is smaller than the catheter.

Keywords
Thrombectomy, stroke, catheter, feasibility, technique
Received 27 October 2023; accepted: 4 January 2024

Introduction 0.074′′ . These catheters provide support for delivering


other devices to treat distal vessel occlusions and have
Acute ischemic stroke (AIS) is a significant cause of mor- led to improved revascularization rates due to the increased
bidity and mortality worldwide.1 Medical management of aspiration force.6,7
AIS with antithrombotic and thrombolytic medications
has strict guidelines and significant side effects.2 The
endovascular management of AIS has witnessed substan- 1
Department of Neurological Surgery, University of California Irvine,
tial advancements over the past decade, leading to mech- Orange, CA, USA
2
anical thrombectomy becoming a safer and more effective University of Arizona, College of Medicine, Tucson, AZ, USA
3
Carondelet Neurological Institute, St. Joseph’s Hospital, Tucson, AZ, USA
treatment option.3,4 In 2013, the largest available reperfu- 4
University of California Los Angeles, David Geffen School of Medicine, Los
sion catheter was the 5MAX ACE (Penumbra, Alameda, Angeles, CA, USA
CA) with a 0.060′′ inner diameter (ID). After introduction, 5
College of Arts and Science, Syracuse University, Syracuse, NY, USA
6
this catheter increased in adoption due to its combination Department of Neurosurgery, University of Rochester, Rochester, NY, USA
7
Department of Neurosurgery, University of California Los Angeles, Los
of navigability for a large bore size and ability to provide
Angeles, CA, USA
direct aspiration.5 Further advancements introduced even
Corresponding author:
larger catheters in 2015: the ACE64 and ACE68 with IDs Jessica K Campos, Department of Neurological Surgery, University of
of 0.064′′ and 0.068′′ , respectively. Today reperfusion California Irvine, Orange, CA, 92686, USA.
catheters boast even larger IDs between 0.071′′ and Email: [email protected]
2 Interventional Neuroradiology

Superbore 0.088′′ catheters designed for intracranial thrombectomy cases, Zoom 88 was navigated triaxially
use are the most recent advancement in endovascular tech- over Zoom 71 and Zoom 35 (ID 0.071′′ and 0.035′′ ,
nology for ischemic stroke. If advanced to the M1 respectively) to the face of the clot in the MCA. The
segment of the middle cerebral artery (MCA), superbore Penumbra Aspiration Pump or Zoom Pump and Zoom
catheters can achieve distal flow arrest due to their large POD were used to apply a vacuum through all the cathe-
outer diameter (OD) relative to the diameter of the ters and aspirate the clot. If a stentriever was used, Zoom
M1-MCA.8 This size advantage may minimize the risk 71 or 55 with Zoom 35 and a microwire were advanced
of embolic showers from clot fragmentation, potentially through Zoom 88 to the face of the clot; the Zoom 35
improving neurological outcome.9 Applying aspiration was removed and a 0.021′′ microcatheter was utilized to
when positioned near the face of the clot, and when deploy a stentriever. Zoom 88 was advanced over the
other smaller reperfusion catheters are used, also has the stentriever to the clot, before removing the stentriever
potential to increase first-pass success rates and improve under vacuum aspiration through the Zoom 88.
the final degree of recanalization.10 Furthermore, com- Follow-up angiography was performed to confirm revas-
pared to the proximal position attained with contemporary cularization before concluding the case.
balloon guide catheters, utilization of 088 superbore
catheters in the MCA along with 071 and 055 thrombec-
tomy catheters reduces the distance between the thromb-
Data collection
ectomy and flow-arrest catheters, consequently lowering The patient charts were reviewed for baseline characteris-
the likelihood of clot fragmentation. tics including age, sex, comorbidities, and presenting
Zoom 88 (Imperative Care, Campbell, CA) is a 0.088′′ National Institutes of Health Stroke Scale (NIHSS).
ID, 2.74 mm OD, a catheter designed for acute mechanical Administration of thrombolytic and thrombus location
thrombectomy. The catheter has an angled distal tip that is with laterality were evaluated. The MCA-M1 diameter
thought to enhance suctioning force on thrombus due to was measured at proximal, mid, and distal locations
higher surface area. The safety and feasibility of using using the anterior–posterior angiography view on digital
Zoom 88 within MCA segments smaller than the catheter subtraction angiography (DSA) before and after thromb-
diameter have not been established. We herein report our ectomy. All measurements were taken using autocalibra-
initial experience navigating Zoom 88 to the MCA seg- tion to limit magnification errors. Procedural data
ments and using it to support AIS thrombectomy. To the included system description, total fluoroscopy time, total
best of our knowledge, this is the first known report of procedural contrast (mL), and radiation dose (mGy).
its kind. Proximal internal carotid artery (ICA) tortuosity was char-
acterized by petrous and cavernous grading.11 Outcomes,
including modified thrombolysis in cerebral infarction
Materials and methods (mTICI) reperfusion grade and the number of passes,
were obtained. All cases were reviewed for catheter-
Patient inclusion
related vessel injury.
A prospectively maintained Institutional Review Board
(IRB) approved institutional database of the senior
authors was retrospectively reviewed. Patient charts Statistics
from April to August 2023 were reviewed. We did not One-sided paired t-tests were used to assess if the prox-
collect individual patient consent as all data was deidenti- imal, middle, or distal M1 diameters significantly
fied and stored in a secure IRB-approved database per our increased between prethrombectomy and postthrombect-
local IRB protocols. Consecutive cases with Zoom 88 omy measurements. A p-value of .01, corresponding to
navigation to the MCA-M1 or beyond in the setting of a 99% confidence level, was considered statistically sig-
mechanical thrombectomy for AIS were selected for ana- nificant. All calculations were completed using Minitab
lysis. Patients were excluded if Zoom 88 was not used in 21.4.0 statistical software (Minitab Inc., State College,
the MCA or the occlusion location was not in the MCA. PA). Discrete datapoints, including patient demographics,
baseline characteristics, effectiveness, and safety end-
points were summarized with rates. The mean and stand-
Procedural technique ard error were generally reported for continuous data.
All procedures were performed in an emergency setting
under general anesthesia using femoral access. An 8
Results
French short sheath was introduced into the femoral
artery using the Seldinger technique and maintained Between April 2023 and August 2023, 20 consecutive
under continuous flush. Under real-time fluoroscopy, a MCA thrombectomy cases using angled-tip catheters
Neuron Select (Penumbra, Alameda, CA) and Zoom 88 were identified. Baseline characteristics of study patients
were advanced into the aortic arch over a 0.035′′ guide- are presented in Table 1. Shortly, slightly over half (n =
wire. The common carotid artery was selected, and the 12, 60%) of patients were female and the average present-
Zoom 88 was advanced over the Neuron Select and guide- ing NIHSS and patient ages were 15.1 ± 1.97 and 73.2 ±
wire into the internal carotid artery. For aspiration 3.05 years, respectively. Thrombolytics were administered
Campos et al. 3

Table 1. Baseline characteristics of study patients, procedural characteristics, and vessel diameters.

Number/average Percent/SE

Demographics
Total cases 20
Average age (years) 73.2 3.05
Female sex 12 60%
Thrombolytics 6 30%
Presenting NIHSS Score 15.2 1.97
Comorbidities
Hypertension 9 45%
Atrial fibrillation 5 25%
Type 2 diabetes 2 10%
Cancer 1 5%
Patent foramen ovale 1 5%
Thrombus details
Laterality
Right 14 70%
Left 6 30%
Location
M1 10 50%
Aspiration only 8 80%
Stentriever and aspiration 2 20%
M2 10 50%
Aspiration only 1 10%
Stentriever and aspiration 9 90%
Patient anatomy
Petrous grade
Hockey stick 8 40%
Some recurve 6 30%
Question mark 6 30%
Cavernous
1a 8 40%
1b 5 25%
2 1 5%
3 1 5%
4 5 25%
Systems used
Zoom 88/Zoom 71/Zoom 35 9 45%
Zoom 88/Zoom 71/Zoom 35/Trak 21/Tiger 017 1 5%
Zoom 88/Zoom 71/Trevo 6 × 37 1 5%
Zoom 88/Zoom 71/Trak 21/Trevo 4 × 41 1 5%
Zoom 88/Zoom 71/Trak 21/Trevo 4 × 28 2 10%
Zoom 88/Zoom 55/Trak 21/Tiger 013 2 10%
Zoom 88/Zoom 55/Trak 21/Trevo 4 × 41 2 10%
Zoom 88/Zoom 55/Trak 21/Trevo 4 × 28 2 10%
Case characteristics
Fluoroscopy time (minutes) 14.9 2.2
Contrast amount (mL) 22.6 3.0
Radiation exposure (mGy) 554.8 82.7
Procedural outcomes
mTICI 2C/3 18 90%
mTICI 2B 2 10%
First-pass efficacy 8 40%
Average number of passes 1.9 0.23
Vasospasm 1 5%
Catheter-related dissection 0 0%

M1 diameter (mm) Proximal Middle Distal

Prethrombectomy 2.36 ± 0.07 2.09 ± 0.08 2.00 ± 0.11


Postthrombectomy 2.34 ± 0.07 2.16 ± 0.08 1.97 ± 0.10
p-value .384 .001 .214

NIHSS: National Institutes of Health Stroke Scale, SE: standard error; mTICI: modified thrombolysis in cerebral infarction reperfusion grade.
4 Interventional Neuroradiology

Figure 1. (A) An adult patient with NIHSS of 26 presents with a distal M1 occlusion (black arrow). (B) Navigation of the Zoom 88 (2.74 mm
OD) (yellow arrow) with Zoom 71 (orange arrow) to the 2 mm M1 for direct thrombus aspiration. (C) Postangiography demonstrating TICI 3
with M1 enlargement post Zoom 88 thrombectomy.
NIHSS: National Institutes of Health Stroke Scale; TICI: thrombolysis in cerebral infarction.

to a minority of patients. The M1 and M2 occlusions were these increases in aspiration catheter ID include enhancing
evenly distributed. The most common petrous grade tortu- the clot engagement force exerted by the catheter while
osity was a hockey stick shape (n = 8, 40%), followed by simultaneously decreasing the force needed to ingest the
some recurve (n = 6, 30%) and a question mark (n = 6, clot. These features have resulted in faster procedures,
30%). The most common cavernous grade was 1a (n = 8, fewer passes to achieve successful reperfusion, and
40%), followed by 1b (n = 5, 25%), 4 (n = 5, 25%), improvements in the achieved level of reperfusion.6,12
2 (n = 1, 5%), and 3 (n = 1, 5%). There was a single Despite the evident clinical benefits associated with the
case of mild vasospasm in the proximal ICA due to tortu- use of larger diameter catheters for neurovascular interven-
ous anatomy that was successfully managed with 10 mg tions, concerns persist regarding the safety of employing
of verapamil. 0.088′′ catheters in M1 vessels that are nominally narrower
Two thrombectomy techniques were used, aspiration than the catheter itself.
only for nine cases (45%) and stentriever with aspiration Guide catheters of 0.088′′ ID have long been used as
in 11 cases (55%). Of the M1 occlusions, aspiration only neurovascular guides to support the delivery of interven-
was used in 80% (n = 8) of cases and aspiration with tional devices. Early use of 0.088′′ catheters in the neuro-
stentriever in 2 (20%) cases. Ninety percent (n = 9) of M2 vasculature focused on stiffer catheters (6F Shuttle, Cook
occlusions were managed with a concomitant aspiration Medical, Bloomington, IN) that were utilized to deliver
and stentriever technique, and 1 (10%) case used aspiration carotid stents and distal cerebral protection devices, with
only with the placement of Zoom 88 into the M1. The the Shuttle typically positioned near the common carotid
average fluoroscopy time was 14.9 ± 2.2 min, radiation artery bifurcation.13 While these stiffer catheters are some-
doses were 554.8 ± 82.7 mGy, and contrast volume was times used to support mechanical thrombectomy proce-
22.6 ± 3.0 mL (Table 1). First-pass mTICI ≥2C recanaliza- dures,14 0.088′′ catheters with softer distal tips (Neuron
tion was achieved in 40% (n = 8) of cases and the average Max) were developed which allowed for more consistent
number of passes was 1.9 ± 0.23. Final mTICI ≥2B recana- navigation to the distal cervical segment of the internal
lization was achieved in all cases (Table 1). Proximal and carotid artery and delivery of thrombectomy catheters and
distal M1 diameters did not significantly differ between pre- other devices directly into the intracranial vasculature.15
thrombectomy and postthrombectomy; a small (0.07 mm) In recent years, newer 0.088′′ catheters with longer flex-
but statistically significant increase in the middle M1 diam- ible segments have been developed which can be consist-
eter was observed postthrombectomy (Table 1). ently navigated past the cervical ICA and into more distal
neurovasculature. The infinity-long sheath (Stryker) was
designed with a 9.5 cm distal flexible segment that
Discussion enables it to track past challenging tortuosity in the cervical
Over the last two decades, there has been a consistent trend ICA and the TracStar Large Distal Platform (Imperative
toward developing larger bore aspiration catheters that can Care) was designed with a 14 cm distal flexible segment
navigate the tortuous anatomy of neurovasculature. The that enables it to consistently track intracranially into the
first stroke aspiration catheters were released in 2007 and cavernous and clinoid segments of the ICA.16–18 The
had IDs between 0.026′′ to 0.041′′ . Over the following Zoom 88 catheters used in our study have an even longer
years, aspiration catheters continued to increase in size 18 cm distal flexible segment and have previously been
with devices like the 0.060′′ ID 5MAX ACE released in reported reaching locations up to the M1 segment of the
2013, 0.068′′ ID ACE68 in 2015, and now there are mul- MCA.19–21
tiple large bore aspiration catheters with IDs between The ability to track 0.088′′ catheters intracranially into
0.070′′ and 0.074′′ available. The primary incentives for the distal ICA and MCA, combined with prior observed
Campos et al. 5

Figure 2. (A) A sexagenarian patient with NIHSS of 20 presents with a thrombus in the superior division of the proximal left M2 (black
arrow). (B) Navigation of Zoom 88 (yellow arrow) with Zoom 71 (orange arrow) to the M1 with deployment of Trevo 4 × 28 (white arrows)
stentriever in the superior M2 via the Trak 21 microcatheter (black arrow). (C) Postangiography demonstrating TICI 3 with enlargement of
proximal M1 post Zoom 88 stentriever-assisted thrombectomy.
NIHSS: National Institutes of Health Stroke Scale; TICI: thrombolysis in cerebral infarction.

improvements in reperfusion success rates using larger ID In addition to excellent periprocedural safety, the
aspiration catheters, will likely see a natural progression results from our study also showed a high rate of first-pass
toward performing aspiration thrombectomy with superb- success and self-adjudicated final mTICI ≥ 2C reperfu-
ore 0.088′′ catheters. While no superbore 0.088′′ catheters sion. The final mTICI ≥ 2C rate of 90% observed in our
are currently indicated for reperfusion, initial reports have cohort is notably higher than in prior studies such as
shown promising results associated with using these cathe- COMPASS which reported a 56% rate of mTICI ≥ 2C
ters to support thrombectomy. Nogueira et al. found prom- when using the current generation large bore aspiration
ising results in a series of early cases using the Zoom 88 and catheters and stent retrievers.22 While these results
TracStar LDP catheters within the ICA, M1, and Basilar should be interpreted with caution given the small
arteries, with an observed first pass mTICI 3 rate of sample size in our study, they appear to be in line with
60%.20 However, the authors noted that navigation of the the other research demonstrating improved reperfusion
0.088′′ catheters into the more distal aspects of the M1 success when using intracranially positioned flexible
segment was avoided due to concerns about the vessel super-bore 0.088′′ catheters to support stroke thrombec-
diameter (2.6 mm) being smaller than the OD of the cath- tomy.20 Although first-pass efficacy (FPE) in our study
eter (2.74 mm). aligns with results from larger trials in literature, it
Within our cohort, we found that the Zoom 88 catheter remains uncertain whether the presence of Zoom 88 in
was able to successfully navigate simple and tortuous MCA confers a notable advantage in terms of FPE.20
anatomy in the petrous and cavernous ICA before being Our study has several limitations. As this was a retro-
advanced to or beyond the M1 (Table 1). Figures 1 and spective study without core lab adjudication, case selection,
2 show the more challenging anatomies the angled-tip and endpoint assessments may be biased. However, we
catheters navigated in this study, which included multiple included consecutive patients treated by a single operator
>180° bends and loops. Despite the relatively large differ- to minimize the potential bias. The relatively small
ence in size between the 2.74 mm OD Zoom 88 catheters sample size also limits the generalizability of our findings
and the smaller diameter M1 vessels encountered in this to a broader patient population. Factors such as variations
study, all procedures were completed without noted dis- in the aortic arch and tortuosity of proximal vessels might
sections or significant vascular injury (Figure 3). This impact the number of cases wherein a 0.088′′ catheter can
establishes the technical feasibility and safety of utilizing effectively navigate to the MCA, although in our study
0.088′′ catheters for thrombectomy within these narrower- patients with high-grade tortuous petrous and cavernous
diameter MCA vessels. We also found that the average internal carotid arteries were incorporated. M1 measure-
diameter of the M1 vessels did not appear to have a clin- ments were taken using an anterior–posterior view on
ically significant increase after completing the thrombec- DSA, which subjects the vessel measurements to a magni-
tomy procedures, though small numeric increases fication error. To limit this, all measurements were taken
between 0.1 mm and 0.2 mm were observed in some using the autocalibration technique. Despite these limita-
cases (Figures 1 and 2). These findings further support tions, the analyses presented in our report provide a
that there was minimal damage to the vessel wall and that crucial preliminary insight into the safety and feasibility
superbore angled-tip catheters can be safely used within of positioning and using the Zoom 88 catheters within the
smaller-diameter vessels (Supplementary Video 1). We M1/M2 arteries as part of mechanical thrombectomy proce-
believe that the excellent safety observed in this cohort dures for AIS which has not previously been reported. The
may be associated with flexibility within the distal end Zoom 88 catheters are also being studied as part of the
of the catheter. ongoing prospective multicenter clinical investigation of
6 Interventional Neuroradiology

Figure 3. Illustration depicting Zoom system placement of superbore Zoom 88, Zoom 71, and Zoom 35 catheters for an M2 segment
occlusion. Using the system designed for coaxial tracking with minimal endoluminal step-off, the Zoom 88 superbore catheter is placed
safely within an M1 segment that measures less than 2.7 mm (size of Zoom 88). Copyright Tess Marhofer. Published with permission.

the Zoom Reperfusion System (NCT04129125) which stroke thrombectomies even when the diameter of the
includes independent adjudication of efficacy and safety M1 was smaller than the OD of the Zoom 88. Based on
endpoints. This will further address the limitations noted our results, the M1 vessel size does not appear to be a sig-
in our study. Another limitation of our study is the varied nificant limitation to the navigation of superbore angled-
techniques used, such as aspiration alone or in combination tip catheters to the MCA for mechanical thrombectomy
with a stent retriever. Given our small sample size, the procedures.
superiority of one technique over the other cannot be deter-
mined. Our primary aim is to highlight the feasibility of Authors’ Notes
placing the superbore 0.088 catheters in MCA vessels Jessica K Campos and Benjamen M Meyer contributed equally
that are nominally smaller. to this work. This material was accepted as an abstract and elec-
tronic poster to the 2023 Society of Vascular and Interventional
Neurology meeting in Miami, Florida, USA.
Conclusion
Within our study, we demonstrated that it is safe and feas- Data sharing statement
ible to use the Zoom 88 catheter to support M1 and M2 There is no additional unpublished data from this study.
Campos et al. 7

Declaration of conflicting interests 8. Gunnal SA, Farooqui MS and Wabale RN. Study of middle
The author(s) declared the following potential conflicts of inter- cerebral artery in human cadaveric brain. Ann Indian Acad
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this article: Alexander L. Coon is a consultant for Medtronic
emboli with proximal flow control during mechanical
Neurovascular, MicroVention-Terumo, Stryker Neurovascular,
thrombectomy: a quantitative in vitro study. Stroke 2013;
Cerenovus, Rapid Medical, Avail MedSystems, Imperative Care,
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Deinde, InNeuroCo, Q’apel and a proctor for MicroVention-
10. Munoz A, Jabre R, Orenday-Barraza JM, et al. A review of
Termo, Stryker Neurovascular, and Medtronic Neurovascular.
mechanical thrombectomy techniques for acute ischemic
Li-Mei Lin is a proctor for Medtronic Neurovascular, Stryker
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Neurovascular, MicroVention-Terumo and a consultant for
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Medtronic Neurovascular, Stryker Neurovascular, MicroVention-
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Terumo, Rapid Medical, and Balt. Geoffrey P. Colby is a consult- ural complexity in pipeline embolization. J Neurointerv
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Medical, Cerenovus, and Stryker Neurovascular. Matthew 12. Schartz D, Ellens N, Kohli GS, et al. Impact of aspiration
Bender is a proctor Stryker Neurovascular. All other authors catheter size on clinical outcomes in aspiration thrombec-
have no conflict of interest. No author received financial tomy [published online ahead of print, 2022 Aug 2].
support in conjunction with the generation of this submission. J Neurointerv Surg. 2023;15:e111–e116.
13. Patel RS and Katzen BT. Carotid artery stenting: what
Funding you need to know. Semin Intervent Radiol 2009; 26:
The authors received no financial support for the research, 324–332.
authorship, and/or publication of this article. 14. Turk A, Manzoor MU, Nyberg EM, et al. Initial experience
with distal guide catheter placement in the treatment of cere-
ORCID iDs brovascular disease: clinical safety and efficacy.
J Neurointerv Surg 2013; 5: 247–252.
Jessica K Campos https://orcid.org/0000-0003-1075-0764
15. Ansari SA, Darwish M, Abdalla RN, et al. GUide sheath
Benjamen M Meyer https://orcid.org/0000-0002-5773-1619
Advancement and aspiRation in the Distal petrocavernous
internal carotid artery (GUARD) technique during thromb-
Supplemental material
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Supplemental material for this article is available online. Am J Neuroradiol 2019; 40: 1356–1362.
16. Lin LM, Bender MT, Colby GP, et al. Use of a next-
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