Use of drug-eluting,balloon-expandable resolute onyx coronary stent as a novel treatment strategy for vertebral artery ostial stenosis: Case series

Abstract

Introduction

Vertebral artery (VA) ostial stenosis is notoriously difficult to treat using bare-metal stents owing to high rates of restenosis and stent kinking and breakage. We investigated the safety and effectiveness of treatment with a drug-eluting, balloon-expandable coronary stent (Resolute Onyx, Medtronic).

Methods

Our prospectively maintained database was retrospectively searched for consecutive patients diagnosed with VA ostial stenosis who underwent Resolute Onyx stenting with/without angioplasty between January 1, 2015 and January 1, 2022. Patient demographics and clinical and radiographic presentations were recorded. Occlusion location, stenosis severity, contralateral disease, devices used, and intraprocedural and postprocedural complications were noted. Outcomes were assessed based on new or recurrent stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH). Patients were followed up clinically and with radiographic imaging for in-stent stenosis.

Results

Twenty-six patients were included in our study (21 men [80.8%]; mean age 70.3 ± 9.8 years). Symptomatic patients presented with TIA (11/26, 42.3%) and stroke (10/26; 38.5%). Mean stenosis in the study cohort was 74.9 ± 13.0%. One (3.8%) intraprocedural complication was encountered whereby the stent failed to open despite several attempts and was exchanged with a new one without issues. No in-hospital postprocedure stroke, TIA, or mortality was reported. During a mean 16.2 ± 13.6 months’ follow up, two patients developed symptomatic in-stent restenosis that was treated with balloon angioplasty.

Conclusions

We report the first case series of Resolute Onyx drug-eluting stenting including 30-day postprocedure stroke/TIA rates and clinical/radiographic follow up and demonstrate safe and effective treatment of symptomatic and asymptomatic VA ostial stenosis.

Keywords

Vertebral artery ostial stenosis stenting angioplasty RESOLUTE ONYX drug-eluting stent

Introduction

Posterior circulation strokes account for approximately 20–25% of all ischemic strokes.^1,2 Angiographic studies have shown that the proximal extracranial vertebral artery (VA) is the second-most common site of stenosis after the carotid bifurcation.³ Patients with symptomatic VA stenoses have a high risk of recurrent strokes, particularly within the first month; and those with symptomatic VA stenoses are now routinely treated with stenting and angioplasty with low complication rates.^4–6

Two of the major treatment options for VA ostium stenosis include balloon angioplasties and stenting.⁷ Bare metal, self-expanding, balloon-expanding, and drug-eluting stents (DES) have been used for vertebral ostial stenosis, but the post-stenting restenosis rates are higher than those seen for carotid artery stenting.^7–12 Potential causes for the higher restenosis rates include the angle of the vertebral ostium at the subclavian artery and the intrinsic properties of various stents that account for a decreased opening force and decreased maneuverability and result in suboptimal opening of the stenosis.^10,13,14

The Resolute Onyx Zotarolimus-eluting stent (Medtronic) is a balloon-expandable, coronary stent that is premounted on a rapid-exchange or an over-the-wire stent delivery system.¹⁵ The Resolute Onyx drug-eluting stent (DES) has shown good technical success in the treatment of intracranial atherosclerotic disease due to its swaged shape and thinner struts, which provide greater navigability and stability.¹⁶ To our knowledge, we report the first case series including 30-day stroke and transient ischemic attack (TIA) rates and further clinical and radiographic follow up of the use of the Resolute Onyx DES and its utility in specifically treating vertebral ostial stenosis and its advantages in navigating the tortuous turn-offs and angles that are often seen at the VA ostium.

Methods

Case series data collection

After receiving institutional review board approval, our prospectively maintained database was retrospectively searched for consecutive patients diagnosed with VA ostial stenosis who underwent stenting with the Resolute Onyx DES with or without angioplasty between January 1, 2015 and January 1, 2022. All patients or their legally authorized representatives had provided informed consent for the procedure, including the off-label use of the stent.

Patient demographics (age, sex, race-ethnicity, and comorbidities), clinical and radiographic presentations, and time from symptom onset to treatment were recorded. Occlusion location, stenosis severity, contralateral stenosis, and devices used were noted. Intraprocedure and postprocedure complications, as well as clinical and radiographic outcomes were collected. Patient presentation was divided into three categories: ischemic stroke, TIA, and asymptomatic. For patients who presented with ischemic symptoms, the presenting National Institute of Health Stroke Scale (NIHSS) was used to measure the severity of the initial neurologic deficit. Stroke was defined as a diffusion-weighted imaging change detected on magnetic resonance (MR) imaging,

The VA occlusion site was determined on digital subtraction angiography (DSA). Mori classification was used to determine the morphologic characteristics of the VA ostial stenosis.¹⁷ Stenosis were classified into one of three categories: Mori A, a short (<5 mm) and concentric lesion; Mori B, a tubular or extremely eccentric lesion (between 5 and 10 mm); and Mori C, a diffuse lesion with a long length (>10 mm). Periprocedural outcomes assessment was based on any new or recurrent stroke, TIA, or intracranial hemorrhage (ICH). Incidence of stroke or TIA at last clinical follow up was also noted. Symptomatic in-stent restenosis observed during follow-up evaluation was treated with angioplasty. Patients were followed up both clinically and with radiologic imaging with computed tomography (CT) angiography or MR angiography.

Vertebral artery stenting procedural details

All patients were treated with dual antiplatelet agents (aspirin 325 mg daily and clopidogrel 75mg or ticagrelor 80mg daily) preceding the stenting procedure, and therapeutic levels were checked preprocedurally. Patients who were placed on clopidogrel and found to be nonresponders with a subtherapeutic response were switched to ticagrelor, and therapeutic levels and effect were confirmed. A micropuncture kit was utilized along with a modified Seldinger technique to introduce a 6- to 8-French (F) sheath via a femoral or radial approach to obtain arterial access. After an arterial run was performed to confirm proper placement of the sheath, heparin was administered to achieve an activated clotting time of >200 s. After confirmation, a guide micro catheter and micro guidewire were selected at the discretion of the operator and introduced and utilized to navigate across the area of VA ostial stenosis under roadmap guidance. The micro guidewire was then advanced into the mid-distal V2 segment of the VA. The microcatheter was then removed, and the Resolute Onyx DES was advanced over the area of stenosis. It was important to allow for adequate overhang of the stent into the subclavian parent artery. Because the Resolute Onyx is a balloon-mounted stent, predeployment angioplasty was typically performed. A Flash ostial balloon system (Cardinal Health) was then advanced over the microwire and positioned within the stent. The Flash ostial balloon was inflated to nominal pressure and in-stent angioplasty was then completed. Poststenting angioplasty was performed if satisfactory opening of the stenosis was not evident on a poststenting angiographic run. The decision to conduct poststenting angioplasty was determined on a case-by-case basis and dependent on adequate stent deployment and vessel recanalization. Poststenting angiographic runs were obtained to measure any residual stenosis and to confirm arterial patency. Patients were monitored in the neurointensive care unit overnight postprocedure. All patients were kept on dual antiplatelet therapy (DAPT) for at least 3 months postprocedure.

Statistical analysis

Continuous variables were reported as means or medians and respective standard deviations (SD) and interquartile ranges (IQR) according to data normality. Categorical variables were reported as frequencies.

This case series has been reported in accordance with the PROCESS Guidelines.¹⁸

Results

A total of 26 patients were included in our study. The mean age of the cohort was 70.3 ± 9.8 years, and 21 patients (80.8%) were men. Hypertension was the most common comorbidity (17 of 26 patients; 65.4%), followed by hyperlipidemia present in 14 patients (53.8%). Most patients in our cohort were identified as White (88.5%). A majority (66.7%) had a current or past smoking history. Patient demographics are further detailed in Table 1.

Table 1.

Patient demographics and presentation characteristics.

Variable	n (%)
Age, years (mean, SD)	70.3 ± 9.8
Male-to-Female Ratio	21:5
Race-Ethnicity
White	23 (88.5)
African-American	3 (11.5)
Comorbidities
Diabetes mellitus	7 (26.9)
Smoking status*
Current	9 (37.5)
Former	7 (29.2)
Never	8 (33.3)
Presenting symptoms
Stroke	11 (42.3)
TIA	10 (38.5)
Asymptomatic (incidentally identified vertebral ostial stenosis)	5 (19.2)
Hypertension	17 (65.4)
Hyperlipidemia	14 (53.8)
NIHSS score of patients presenting with stroke or TIA (median, IQR)	1.5 (0.5–3.5)
Days from presenting symptom(s) to procedure (mean, SD)	35.8 ± 44.9

*Smoking status was not available for 2 of the 26 included patients.

Abbreviations: IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; SD, standard deviation; TIA, transient ischemic attack

The mean degree of VA ostial stenosis for the entire cohort was 74.9 ± 13.0%. Ten patients (38.5%) also had contralateral VA artery stenosis present, with a mean percentage of stenosis of 85.9 ± 20.1%. Indications for stenting included TIA in 11 patients and stroke. Median NIHSS score upon presentation for symptomatic (TIA or stroke) patients was 1.5 (interquartile range, 0.5–3.5). Five of the 26 patients were clinically asymptomatic and had incidentally found VA ostial stenosis and, after discussion of the risks and benefits of the procedure, decided to proceed with stenting. The mean degree of stenosis in the asymptomatic patients was 81.6 ± 2.7%. Additional details are found in Tables 1 and 2.

Table 2.

Summary of lesion- and procedure-related characteristics.

Variable	n (%)
Stenosis location
Left side	12 (46.2)
Right side	14 (53.8)
Stenosis % (mean, SD)	74.9 ± 13.0
Mori classification
Type A	18 (69.2)
Type B	5 (19.2)
Type C	3 (11.6)
Contralateral stenosis	10 (38.5)
Stenosis % (mean, SD)	85.9 ± 20.1
Access artery site
Radial	14 (53.8)
Femoral	12 (46.2)
Poststent deployment angioplasty	6 (23.1)
Procedural complications	2 (7.7)
Device malfunction	1 (3.8)
Dissection	1 (3.8)
Postprocedure residual stenosis % (mean, SD)	5.71 ± 8.56
Complications within 72 h of procedure*
Repeat stroke	0 (0)
De novo stroke	0 (0)
ICH	0 (0)
Months to last clinical follow up (mean, SD)	16.2 ± 13.6
Within 30 days
Had 30-day follow up*	21 (80.8))
Stroke or ICH at 30 day follow up	0 (0)
At last clinical follow up
Stroke	1 (3.8)
TIA	0 (0)
Restenosis**
In-stent restenosis present	2 (7.7)
In-stent restenosis treated	2 (7.7)

Abbreviations: ICH, intracranial hemorrhage; SD, standard deviation; TIA, transient ischemic attack

*Documentation was available for 21 of the 26 patients in the series.

**The same 2 patients had in-stent restenosis present and treated.

Fourteen patients (53.8%) had right-sided stenosis and 12 (46.2%) patients had left-sided stenosis. The arterial access approaches were radial in 14 (53.8%) patients and femoral in 12 (46.2%) (Table 2). Envoy XB catheters (Codman Neuro) were the most frequently used micro guide catheters for navigation to the site of the stenosis, and a diverse array of different micro wires were utilized to cross the lesion and exchange the catheter for the Resolute Onyx DES. Additional details on the catheters and micro guidewires used are shown in Table 3. A case of left VA ostial stenosis successfully treated with the Resolute Onyx DES is illustrated in the Figure 1. A single stent was placed in all but two cases. In those cases, a telescoping technique was used for the placement of two stents in each case.

Table 3.

Procedural device details.

Patient	Side of stenosis	Access route	Sheath size (French)	Guide catheter	Micro guide wire
1	Left	Femoral	5	Envoy XB	Hi-Torque Balance Middle Weight
2	Right	Radial	6	Envoy XB	Synchro 2
3	Left	Radial	6	Envoy XB	Synchro 2
4	Right	Femoral	6	Neuron MAX	Spartacore
5	Right	Femoral	6	Envoy XB	0.014-inch Chikai
6	Left	Radial	6	Envoy XB	Spartacore
7	Right	Radial	6	Envoy XB	Spartacore
8	Left	Femoral	6	Envoy XB	Spartacore
9	Left	Femoral	6	Envoy XB	Spartacore
10	Right	Femoral	6	Berenstein Select	Synchro 2
11	Right	Radial	6	Envoy XB	Synchro 2
12	Left	Radial	6	Envoy XB	Synchro 2
13	Left	Radial	6	Envoy XB	Spartacore
14	Left	Radial	6	Envoy XB	0.014-inch Chikai
15	Right	Radial	7	Envoy XB	Synchro 2
16	Right	Radial	7	Envoy XB	Spartacore
17	Right	Femoral	7	Envoy XB	Spartacore
18	Right	Femoral	7	Envoy XB	Synchro 2
19	Right	Radial	7	Rist guiding catheter	0.014-inch Chikai
20	Left	Femoral	8	Cook Shuttle	Spartacore
21	Left	Radial	8	Walrus balloon guide catheter	Aristotle 14
22	Left	Femoral	8	Neuron MAX	0.014-inch Chikai
23	Right	Radial	6	Benchmark	Synchro 2
24	Right	Radial	6	Envoy XB	Synchro 2
25	Left	Femoral	6	Envoy XB	Spartacore
26	Right	Femoral	5	Envoy XB	Spartacore

Guide catheter manufacturers: Benchmark, Penumbra; Berenstein Select, Merit Medical; Cook Shuttle, Cook Medical; Envoy XB, Codman Neuro; Neuron MAX, Penumbra; Rist, Medtronic; Walrus, Q’Apel Medical

Wire manufacturers: Aristotle 14, Scientia Vascular; Chikai .014-inch, Asahi Intecc; Hi-Torque Balance Middle Weight, Abbott Vascular; Spartacore, Abbott Vascular; Synchro 2, Stryker Neurovascular

There was one instance of device malfunction in which there was difficulty deploying the stent. The stent failed to open despite several attempts at deployment. It was exchanged for a new one with successful deployment without further complications. There was an instance of iatrogenic vascular dissection intraprocedurally that was managed conservatively and resolved spontaneously as confirmed by radiographic follow up. No in-hospital mortality was reported. The mean residual stenosis immediately poststenting was 5.71 ± 8.56%. None of the treated patients had any complications in the periprocedural period. Additional details are found in Table 2.

Thirty-day stroke and ICH rates were calculated for the 21 of 26 (80.8%) patients who had documented radiographic and clinical follow up at 30 days. None of those patients had a stroke or TIA. Five of the 26 patients did not have follow-up at the 1-month mark postprocedure. However, 24 (93%) patients had follow up after their procedure with a mean time to last follow-up of 16.2 ± 13.6 months. On follow-up at 3- and 6-months (respectively), 2 patients developed symptomatic in-stent restenosis that was successfully treated with balloon angioplasty in each case. The 2 patients who had no follow-up postprocedure died. One of these patients departed from the hospital against medical advice after the procedure and later presented with a catastrophic stroke. The other patient developed an unrelated gangrene of the extremities and subsequent sepsis and died after experiencing a complicated medical course.

Discussion

We present our institute's experience of treating VA ostial stenosis with a drug-eluting, balloon-mounted coronary stent and report excellent recanalization outcomes, with low rates of complication and restenosis.

Proximal extracranial VA stenosis is the second-most common site of stenosis and occlusion of the vertebrobasilar circulation tree.³ Vertebral artery stenosis is a known cause and risk factor for strokes. Vertebral artery stenoses are routinely treated with stenting and angioplasty procedures with low complication rates.^5,6 However, medical therapy is the initial management of choice for asymptomatic patients with VA stenosis. DAPT is recommended and shown to reduce ischemic events including TIAs and strokes in the posterior circulation.¹⁹ Statins are also recommended given their efficacy in preventing the progression of stroke in the posterior circulation.^20,21 Interestingly, asymptomatic patients with VA ostium stenosis have a higher risk of ischemic stroke than patients without ostial stenosis.²² Symptomatic patients with vertebral ostial stenosis have an even higher risk of recurrent strokes than asymptomatic patients with vertebral ostial stenosis.²³ Although there is no definitive cutoff for asymptomatic vertebral ostial stenosis that would warrant treatment, Kocak et al.²⁴ and Wehman et al.²⁵ advocate for endovascular treatment of high-grade VA stenoses of >50–70%, as seen in our treated cohort of asymptomatic patients with 81.6 ± 2.7% stenosis.

Angioplasty without stenting has been shown to have higher restenosis rates than angioplasty with stenting, and stenting has been shown to be more effective in the long term.²⁶ Several different types of stents have been used for vertebral ostial stenting including bare metal stents, self-expanding stents, balloon-expanding stents, and DES.^9,11,12 Although significant advancements have been made in stent technology and treatment of ostial stenosis, the restenosis rates for VA ostium stenting are higher than those for in carotid stenting.^8,10,15 Cao et al. report that the higher restenosis rate is due to the angle of the VA ostium at the subclavian artery. The types of stents used in cerebrovascular procedures including self-expandable stents and drug-eluting balloon-mounted stents.^13,14 Self-expandable stents have been found to have decreased radial force in opening a tight stenosis, and drug-eluting balloon-mounted stents lack the navigability of other stent types due to the additional drug-eluting element and overall stiffness.^13,14 However, the Resolute Onyx DES has shown good technical success for the treatment of intracranial atherosclerotic disease due to its swaged shape and thinner struts, which provide greater navigability as well as stability.¹⁵

In our series, we were able to demonstrate that the Resolute Onyx DES was a safe stent option for the treatment of VA ostium stenosis. Most of our treated patients were symptomatic (80.8%) and treated with a near-even split of radial and femoral approaches. In our 26 treated cases, both left and right ostial stenoses were treated with either a radial or a femoral approach. Although the optimal way to treat acute ischemic strokes through either access approach is unclear and a need for a prospective trial is highlighted in Siddiqui et al., we are able to show that VA ostial stenoses can be treated via either route.²⁷ Our series also shows that different microwires and guiding catheters can be utilized to successfully deploy the stent. It is important to highlight the need for careful review of preoperative noninvasive vessel imaging. Evaluation of the angle of emergence of the VA off the subclavian arteries, both on the right and left sides, is critical in determining the optimal route of femoral versus radial access for ostial stenting. Although there is no definitive cutoff that is contraindicated for a transradial or transfemoral approach, if there is an acute angle takeoff of the right VA, a right transradial approach would be discouraged. Furthermore, the presence of an aberrant right subclavian artery, left VA originating directly off the aortic arch, or other vessel aberrancies should be carefully looked for on preoperative noninvasive imaging, which would likely dissuade one approach from the other.

Poststenting, it was very important for all patients to be placed on DAPT to prevent occlusion and thromboembolic events, as supported by the results of major intracranial arterial stenosis and stenting trials.²⁸ All patients received this regimen, consisting of aspirin and clopidogrel or ticagrelor, for at least 3 months. Some patients have been found to be nonresponders to clopidogrel and, in such patients, checking this beforehand with a platelet response test and placing patients on a separate antiplatelet agent for dual coverage is imperative.²⁹ Although the length of DAPT post-stenting initially stems from outcomes of carotid artery stenting and DAPT use,³⁰ the use and length of DAPT post-vertebral ostial stenting is not fully clear. With respect to VA stenting in symptomatic patients, patients enrolled in the Vertebral artery Ischaemia Stenting Trial (VIST) were placed on DAPT for at least 6 weeks to reduce thromboembolic complications relating to stenting.⁵ With the use of a novel coronary DES in the neuroendovascular field, our length of DAPT for at least 3 months is a decision made after consideration of different findings in the literature. For example, Khan et al. reported that a short-term course of DAPT (<6 months) for patients receiving coronary stents was associated with fewer hemorrhagic and thromboembolic complications.³¹ Meanwhile, Wilson et al. explain that a shorter duration (1–3 months) of post-stenting DAPT is acceptable for coronary interventions with newer generation DESs given their safety profile and efficacy.³² The heterogeneity of the length of DAPT across different studies highlights the need for additional investigation into the length of DAPT after VA stenting, including ostial stenting.

At a mean last-follow up of 16.2 ± 13.6 months, none of the 24 patients in our series for whom follow-up data were available had experienced new or recurrent symptoms. Furthermore, none of our patients who had follow up had a stroke or ICH within the 30 days after stenting. In-stent stenosis was present on noninvasive imaging at the follow-up appointments of 2 of our patients, and both underwent successful balloon angioplasties with good clinical and radiographic outcomes and follow-up. The 8.7% in-stent restenosis rate in our series is lower than the 25–30% reported by Stayman et al. (2011), who conducted a systematic review identifying 980 patients treated for symptomatic extracranial VA stenosis.⁶

Limitations

The findings of this study should be carefully examined with regard to several limitations. First, the retrospective nature of this study prevented additional data points of interest to be collected and analyzed regarding treatment technique, patient presentation and deficits, and comparative outcomes. Furthermore, limited and heterogeneous reporting of patient presentation, decision to treat, and outcome measures made a detailed consistent comparison of patient treatment outcome variables difficult. Despite the limitations noted above, we hope this report provides a first look at the use of the Resolute Onyx DES for treatment of VA ostial stenosis.

Conclusion

We report the first clinical series investigating the use of the drug-eluting, balloon-expandable Resolute Onyx coronary stent as a safe and effective treatment option for both symptomatic and asymptomatic VA ostial stenosis.

Footnotes

Abbreviations and acronyms

Acknowledgements

The authors thank Paul H. Dressel BFA for formatting the illustration and Debra J. Zimmer for editorial assistance.

Conflict of interest statement

JL, AAB, AOA, KV, KR, MW, AM, TJF –None.

JMC –Consulting Fees: Cerenovus, J&J Medical Device Companies; Integra Lifesciences, Corp.; MIVI Neuroscience, Inc.; Penumbra, Inc.; Stryker, Corp. Support for attending meetings and/or travel: Stryker, Corp.; Penumbra, Inc.

EIL –Consulting fees: Claret Medical, GLG Consulting, Guidepoint Global, Imperial Care, Medtronic, Rebound, StimMed, Misionix, Mosiac, Clarion, IRRAS. Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: Medtronic; Payment for expert testimony: for rendering medical/legal opinions as an expert. Support for attending meetings and/or travel: Reimbursement for travel and food for some meetings with the CNS and ABNS. Stock or stock options: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical.

AHS –Consulting fees: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., Cerenovus, Cerevatech Medical, Inc., Cordis, Corindus, Inc., Endostream Medical, Ltd, Imperative Care, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc., Penumbra, Q’Apel Medical, Inc., Rapid Medical, Serenity Medical, Inc., Silk Road Medical, StimMed, LLC, Stryker Neurovascular, Three Rivers Medical, Inc., VasSol, Viz.ai, Inc., W.L. Gore & Associates. Leadership or fiduciary role in other board, society, committee or advocacy group: Secretary of the Board of the Society of NeuroInterventional Surgery, Chair of the Cerebrovascular Section of the AANS/CNS. Stock or stock options: Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc, Buffalo Technology Partners, Inc., Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cerevatech Medical, Inc., Cognition Medical, CVAID Ltd, E8, Inc., Endostream Medical, Ltd, Imperative Care, Inc., Instylla, Inc., International Medical Distribution Partners, Launch NY, Inc., NeuroRadial Technologies, Inc., Neurotechnology Investors, Neurovascular Diagnostics, Inc., PerFlow Medical, Ltd, Q’Apel Medical, Inc., QAS.ai, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (Purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc. (Purchased 2020 by Medtronic), Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, Adona Medical, Inc., Amnis Therapeutics, Bend IT Technologies, Ltd, BlinkTBI, Inc, Buffalo Technology Partners, Inc., Cardinal Consultants, LLC, Cerebrotech Medical Systems, Inc, Cerevatech Medical, Inc., Cognition Medical, CVAID Ltd, E8, Inc., Endostream Medical, Ltd, Imperative Care, Inc., Instylla, Inc., International Medical Distribution Partners, Launch NY, Inc., NeuroRadial Technologies, Inc., Neurotechnology Investors, Neurovascular Diagnostics, Inc., PerFlow Medical, Ltd, Q’Apel Medical, Inc., QAS.ai, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (Purchased 2019 by Integra Lifesciences, Corp), Rist Neurovascular, Inc. (Purchased 2020 by Medtronic), Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, SongBird Therapy, Spinnaker Medical, Inc., StimMed, LLC, Synchron, Inc., Three Rivers Medical, Inc., Truvic Medical, Inc., Tulavi Therapeutics, Inc., Vastrax, LLC, VICIS, Inc., Viseon, Inc. Other financial or non-financial interests: National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial & CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial.

Contributors

Conception and design: JL, AAB. Acquisition of the data: JL, AOA, AAB. Analysis and interpretation of the data: all authors. Drafting the manuscript: JL, AAB. Critically revising the manuscript: all authors. Reviewed submitted version of manuscript: all authors.

Data availability

Data that support the findings of this study are available from the corresponding author on reasonable request

Ethical approval statement / IRB approval number

Procedures were performed at Gates Vascular Institute, Buffalo, New York.

Informed consent for these procedures, including the off-label use of the stent, and for publication of patient data was provided by each patient or a legally authorized representative.

The institutional review board at the University at Buffalo approved this study (STUDY00005357).

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Muhammad Waqas

Elad I Levy

Adnan H Siddiqui

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