Interventional Neuroradiology最新文献

{"title":"Venous sinus stenosis intracranial hypertension, rethinking idiopathic intracranial hypertension in the setting of venous sinus stenosis: A call for new nomenclature and diagnostic precision.","authors":"Tatiana Abou-Mrad, Ali Alaraj","doi":"10.1177/15910199241285754","DOIUrl":"10.1177/15910199241285754","url":null,"abstract":"<p><p>Idiopathic intracranial hypertension (IIH) is traditionally characterized by elevated intracranial pressure without an identifiable cause, primarily affecting obese women. However, recent evidence suggests that venous sinus stenosis may play a significant role in the pathophysiology of IIH, challenging its designation as \"idiopathic.\" This editorial discusses the limitations of the current nomenclatures and diagnostic criteria, highlighting the importance of routine venography in detecting venous sinus abnormalities, irrespective of a patient's demographic profile. We propose a new nomenclature of this subset of patients to venous sinus stenosis intracranial hypertension in order to promote more accurate diagnosis and targeted treatment, including potential endovascular interventions.</p>","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":" ","pages":"15910199241285754"},"PeriodicalIF":1.7,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Selective intra-arterial hypothermia combined with endovascular thrombectomy for large vessel occlusion: A systematic review and meta-analysis.","authors":"Fahad Alturki,Ahmed Alkhiri,Bander Alsulami,Fawaz F Alotaibi,Aser F Alamri,Bader AlRuhaymi,Elyas M Bakhuraybah,Fahad S Al-Ajlan,Adel Alhazzani,Mohammed A Almekhlafi","doi":"10.1177/15910199241285157","DOIUrl":"https://doi.org/10.1177/15910199241285157","url":null,"abstract":"BACKGROUNDSystemic therapeutic hypothermia may improve outcomes after acute ischemic stroke but increases complications. Selective intra-arterial hypothermia at the ischemic site during endovascular thrombectomy (EVT) theoretically offers benefits with fewer risks. However, there is little clinical evidence to support this approach.METHODSWe searched Medline/PubMed, Embase and Cochrane electronic databases for studies evaluating the safety and feasibility of selective intra-arterial hypothermia as an adjunct to EVT for large vessel occlusion (LVO). Effect sizes with 95% confidence intervals (CIs) were pooled using the fixed-effect model. Odds ratios (ORs) were computed for binary variables, while the mean differences (MDs) were pooled for continuous data.RESULTSOf identified records, five clinical studies involving 463 LVO patients (62.9% male) were included. Of those, 224 (48.4%) patients received adjuvant selective intra-arterial hypothermia, while 239 (51.6%) received EVT alone. Selective intra-arterial hypothermia resulted in higher rates of good functional outcome (modified Rankin scale [mRS] 0-2 at 90-days) (OR 2.07, [95% CI, 1.36 to 3.16]), and lower final infarct volume (MD, -20.96 ml [95% CI, -26.17 to -15.75]) and lower rates of severe disability (mRS 3-5 at 90 days) (OR 0.44 [95% CI, 0.26 to 0.75]). Safety parameters including rates of symptomatic intracerebral hemorrhage, mortality, pneumonia, coagulation abnormalities, and arterial spasm were comparable between groups.CONCLUSIONSThe initial evidence supports the safety and feasibility of selective intra-arterial hypothermia when combined with EVT for LVO. This approach shows promise for advancing research on neuroprotective strategies for ischemic stroke.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"49 1","pages":"15910199241285157"},"PeriodicalIF":1.7,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Venous sinus diverticulum in patients with pulsatile tinnitus: An acquired lesion.","authors":"Mohamad Abdalkader,Piers Klein,Avner Aliphas,Peter Weber,Thanh N Nguyen","doi":"10.1177/15910199241272645","DOIUrl":"https://doi.org/10.1177/15910199241272645","url":null,"abstract":"BACKGROUNDThe etiopathogenesis of venous sinus diverticulum is controversial. Conflicting evidence has been published suggesting that venous sinus diverticulum is either a congenital or acquired lesion.METHODSThis is a case report of a single individual followed for 17 years within a single healthcare system.RESULTSAn early middle-aged woman presented with unilateral pulsatile tinnitus, vertigo, and decreased hearing. Initial imaging was unrevealing. Interval imaging after 13 years revealed the development of an ipsilateral venous sinus diverticulum. The patient was treated via endovascular stenting and coiling of the lesion with complete resolution of symptoms.CONCLUSIONSWe demonstrate that a venous sinus diverticulum in a patient with pulsatile tinnitus is an acquired lesion. Further research is warranted to better elucidate the precise etiology and pathophysiology of acquired venous sinus diverticulum, potentially guiding management strategies.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"65 1","pages":"15910199241272645"},"PeriodicalIF":1.7,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alternative hybrid access in endovascular neurosurgery: Scoping review and technical considerations","authors":"Matias Costa, Juan Vivanco-Suarez, Sean O’Leary, Preston D’Souza, Ravi Nunna, Sabino Luzzi, Daniel Casanova-Martinez, Akshal Patel","doi":"10.1177/15910199241282352","DOIUrl":"https://doi.org/10.1177/15910199241282352","url":null,"abstract":"BackgroundThe common femoral artery and radial artery constitute the most common access sites in contemporaneous endovascular neurosurgery. Oftentimes, it may be impossible to reach the vascular target safely due to different circumstances, necessitating alternative approaches. We aim to review these “last resource” access sites described in the literature, focusing on the technical aspects as a convenient reference.MethodsWe performed a comprehensive literature search of PubMed capturing articles from 1958 to 2022.ResultsWe identified nine alternative approaches for endovascular access, after excluding direct carotid stick: superficial temporal artery access in 60 patients, calvarial foramina access in five patients, occipital artery access in seven patients, middle meningeal artery access in six patients, vertebral artery access in 23 patients and external carotid artery, internal maxillary artery, facial artery or lingual artery in 40 patients. Indications for the use of alternative access points included tortuous or occluded vessels, small vessel calibers, or anatomic variation. Pathologies treated included dural arteriovenous fistulas, arteriovenous malformations, intracranial aneurysms, acute stroke, and intracranial stenosis. Diagnostic brain angiograms were also performed.ConclusionsAlternative vascular access routes expand the proceduralists' toolkit, enhancing the capability to manage complex cerebrovascular interventions. This review advocates for a broader understanding and consideration of these techniques, given their potential to significantly increase treatment options in neuroendovascular surgery.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"14 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"1-Year outcomes of Resolute Onyx Zotarolimus-Eluting Stent for symptomatic intracranial atherosclerotic disease: A multicenter propensity score–matched comparison with stenting versus aggressive medical management for preventing recurrent stroke in intracranial stenosis trial","authors":"Saisree Ravi, Ibrahim A Bhatti, Ravi S Nunna, Syed Khalid, Wondwossen G Tekle, Omar Tanweer, Jan-Karl Burkhardt, Pascal M Jabbour, Stavropoula I Tjoumakaris, Nabeel A Herial, Adnan H Siddiqui, Ramesh Grandhi, Adnan I Qureshi, Farhan Siddiq, Ameer E Hassan","doi":"10.1177/15910199241278033","DOIUrl":"https://doi.org/10.1177/15910199241278033","url":null,"abstract":"BackgroundIntracranial atherosclerotic disease (ICAD) is one of the most prevalent causes of stroke across the world. Endovascular treatment has gained prominence but remains a challenge with unfavorable results. Recent literature has demonstrated that the Resolute Onyx Zotarolimus-Eluting Stent (RO-ZES) is a technically safe option with low complication rates along with 30-day outcomes associated with intracranial stent placement for ICAD with RO-ZES compared to results from the Stenting Versus Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial. Here, we aim to compare outcomes at one year with the SAMMPRIS trial with a multicenter longitudinal study.Materials and methodsProspectively maintained databases across seven stroke centers were analyzed for adult patients undergoing RO-ZES placement for ICAD between January 2019 and May 2023. The primary endpoint was composite of one-year stroke, ICH, and/or death. These data were propensity score matched using age, sex, hypertension, diabetes mellitus, smoking status, and impacted vessel for comparison between RO-ZES and the SAMMPRIS percutaneous angioplasty and stenting groups (S-PTAS).ResultsA total of 104 patients were included, mean age ± SD: 64.9 ± 10.9 years, 25.5% female. Propensity score match analysis of the 104 patients with S-PTAS demonstrated one-year stroke, ICH, and/or death rate of 11.5% in the RO-ZES group and 28.1% in the S-PTAS group (odds ratio 4.17, 95% CI 2.06–8.96, p = 0.001).ConclusionThe RO-ZES system demonstrates strong potential to reduce long-term complications at one year compared with the S-PTAS group. Further prospective multicenter studies are needed to corroborate and build upon these findings.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"16 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perfecting the pour: A novel co-axial technique with sequential injections for optimising cement delivery during sacroplasty","authors":"Mehran Nasralla, Afra Alfalahi, Eef J Hendriks, Kieran Murphy, Roger Smith","doi":"10.1177/15910199241282709","DOIUrl":"https://doi.org/10.1177/15910199241282709","url":null,"abstract":"BackgroundPercutaneous sacroplasty is an effective treatment for painful sacral fractures and tumours, however there is no accepted optimal technique for performing this procedure. This study investigated a novel approach to sacroplasty combining co-axial sacral access, sequential cement injections and hypothermic cement manipulation to improve cement delivery.MethodsThis retrospective study analysed 11 patients who underwent co-axial sacroplasty between April 2023 and March 2024 for treatment of painful insufficiency fractures ( n = 5) or malignant sacral tumours ( n = 6). All cases were performed using biplane fluoroscopy with conebeam CT navigation for planning and monitoring percutaneous access. Procedural details, technical outcomes, and clinical outcomes including Numerical Rating Scale (NRS) pain and analgesic utilisation on a six-point scale were analysed pre-procedure and at follow-up.ResultsTechnical success of was achieved in all cases using this technique. The mean injected cement volume was 20.5 ± 6.4 ml. Median pre-procedural NRS pain scores of 8 (IQR 7.25–8) significantly decreased to 0 (IQR, 0–0.25) at follow-up ( p &lt;.01). The median preprocedural analgesic utilisation score reduced from 3 (IQR, 2–3) to 0 (IQR, 0–2.5) at follow-up ( p &lt;.01). Cement leakage occurred during two cases without associated adverse clinical sequelae. There were no major adverse events.ConclusionCo-axial sequential injection sacroplasty is a safe and effective technique which allows facilitates controlled delivery of cement. Improved control of cement delivery, including around high-risk structures for cement leakage, offers a potential safety advantage over conventional sacroplasty techniques. Further research comparing technical and clinical outcomes to conventional techniques is warranted.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"2 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of flow diverters in retreatment of recurrent intracranial aneurysms—A systematic review and meta-analysis","authors":"Armin Zarrintan, Sherief Ghozy, Seyed Farzad Maroufi, Abdullah Reda, Waleed Brinjikji, Ramanathan Kadirvel, David F Kallmes","doi":"10.1177/15910199241282713","DOIUrl":"https://doi.org/10.1177/15910199241282713","url":null,"abstract":"Background and purposeTreatment of recurrent intracranial aneurysms after their initial therapy has been a significant challenge in the field of neurointervention. Recently flow diverters stents are widely used for treating intracranial aneurysms. In this systematic review and meta-analysis, we assessed the safety and efficacy of flow diverter in treating recurrent or recanalized intracranial aneurysms.MethodsThis meta-analysis is reported following the PRISMA 2020 guidelines. We conducted a systematic review of literature in the PubMed, Embase, Web of Sciences, and Scopus databases. Pooled prevalence and the corresponding 95% are calculated from extracted data using a random-effect model.ResultsThe systematic literature search included 21 studies involving 411 patients, with 135 (32.8%) being male and 276 (67.2%) being females with a total number of 447 aneurysms. The overall rate of adequate occlusion was 90.67% (95% CI: 84.23%–94.65%), and the rates were comparable between the surgery (93.48%), coiling (91.78%), and stenting (85.77%) groups. The overall pooled rate of complete occlusion was 81.80 (95% CI: 71.14%–89.13%). On doing a subgroup analysis, the complete occlusion rates were 89.68%, 84.39%, and 73.47% for the surgery, coiling, and stenting groups, respectively. The overall mortality rate and achieving modified Rankin scale score of 0-2 was 1.28% (95% CI: 0.45%–3.64%) and (95% CI: 89.92%–97.84%), respectively. No significant heterogeneity is noted in the included studies.ConclusionFlow diverter stents are an effective and safe method for retreating recurrent or residual intracranial aneurysms with a high rate of complete and adequate occlusion. The rate of mortality, intracerebral hemorrhage, and overall and procedural complications following using flow diverters for intracranial aneurysms is low.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"97 1","pages":""},"PeriodicalIF":1.7,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of intravenous thrombolysis in stroke patients with unsuccessful thrombectomy.","authors":"Sameh Samir Elawady,Rahim Abo Kasem,Hidetoshi Matsukawa,Conor Cunningham,Mohamed Mahdi Sowlat,Noah Lee Nawabi,Atakan Orscelik,Joshua M Venegas,Julio Isidor,Hasna Loulida,Ilko Maier,Pascal Jabbour,Joon-Tae Kim,Stacey Quintero Wolfe,Ansaar Rai,Robert M Starke,Marios-Nikos Psychogios,Edgar A Samaniego,Nitin Goyal,Shinichi Yoshimura,Hugo Cuellar,Brian Howard,Ali Alawieh,Ali Alaraj,Mohamad Ezzeldin,Daniele G Romano,Omar Tanweer,Justin Mascitelli,Isabel Fragata,Adam Polifka,Fazeel Siddiqui,Joshua Osbun,Ramesh Grandhi,Roberto Crosa,Charles Matouk,Min S Park,Michael R Levitt,Waleed Brinjikji,Mark Moss,Ergun Daglioglu,Richard Williamson,Pedro Navia,Peter Kan,Reade De Leacy,Shakeel Chowdhry,David J Altschul,Alejandro M Spiotta,Sami Al Kasab","doi":"10.1177/15910199241279009","DOIUrl":"https://doi.org/10.1177/15910199241279009","url":null,"abstract":"BACKGROUNDThe benefit of intravenous thrombolysis (IVT) is well established. We aim to study the benefits of IVT in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO) who underwent unsuccessful mechanical thrombectomy (MT).METHODSWe included AIS patients who underwent MT for anterior circulation LVO with failed recanalization (modified treatment in cerebral ischemia [mTICI] score ≤ 2A). Patients who received IVT prior to MT were compared to those who received MT alone. Propensity score matching using demographic, clinical, radiographic and procedural variables was used to match patients with and without IVT. The primary outcome was favorable 90-day good functional outcome (defined as modified Rankin scale of 0-2), and secondary outcomes included intracranial hemorrhage (ICH), symptomatic ICH (sICH), and 90-day mortality.RESULTSTotally, 610 AIS patients with unsuccessful MT were included. After propensity matching, 219 patients were identified in each group. Median age was 70 years and 73 years in the IVT + MT and MT alone groups, respectively. In the IVT + MT group, final mTICI scores of 0, 1, and 2A were achieved in 92 (42.0%), 33 (15.1%), and 94 (42.9%) patients, respectively, versus 76 (34.7%), 29 (13.2%), and 114 (52.1%) in the MT alone group. The IVT + MT group had greater odds of 90-day good functional outcome (adjusted odds ratio 2.54, 95% confidence interval 1.53-4.32). There were no significant differences in secondary outcomes.CONCLUSIONSIVT is associated with improved functional outcomes in AIS patients with LVO despite unsuccessful MT.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"34 1","pages":"15910199241279009"},"PeriodicalIF":1.7,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188390","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of cerebral venous sinus stenosis by flat panel angiographic CT (FP-CT) to guide treatment for idiopathic intracranial hypertension","authors":"Peter Theiss, Elsa Nico, Tatiana Abou-Mrad, Mpuekela Tshibangu, Adrusht Madapoosi, Laura Stone McGuire, Ali Alaraj","doi":"10.1177/15910199241267318","DOIUrl":"https://doi.org/10.1177/15910199241267318","url":null,"abstract":"IntroductionCerebral venous sinus stenting (CVSS) is an effective treatment for idiopathic intracranial hypertension (IIH) secondary to dural venous sinus stenosis. Traditional selection of patients for CVSS has been made by microcatheter manometry, but pressure measurements are often equivocal. Here we present the results of a series of cases in which venous flat-panel CT (FP-CT) was used as an adjunct to microcatheter manometry to improve decision making and precise stent placement during CVSS.MethodsTen consecutive patients with IIH underwent angiography with microcatheter manometry and venous FP-CT, with CVSS if indicated by the results. Cross-sectional measurements of the narrowed sinus were obtained on FP-CT before and after stenting. After the procedure, clinical outcomes were tracked. Follow-up with quantitative MRA with sinus flow measurements was also performed, when available.ResultsThere was an exponential correlation between measured pressure gradient and degree of stenosis calculated using venous FP-CT. All patients with both a high degree of stenosis measured by FP-CT and a high pressure gradient across the stenosis showed a clinical benefit from stenting.ConclusionsTrue measurement of the cross-sectional area of the dural sinus, made by venous phase FP-CT, has a high degree of correlation with elevated venous pressure gradient across the point of stenosis. Even in a limited series of cases, we found an exponential decrease in flow with increasing severity of stenosis. Furthermore, patients with both an elevated venous pressure gradient and critical stenosis of the sinus on FP-CT showed symptomatic improvement after stenting.","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":"39 1","pages":"15910199241267318"},"PeriodicalIF":1.7,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design.","authors":"Guilherme Dabus, Ajit S Puri, Ben McGuinness, Ryan A Priest, Ansaar T Rai, Bradley A Gross, Osama O Zaidat, Ricardo A Hanel, M Shazam Hussain, Hamza A Shaikh, Joey D English, Thanh N Nguyen","doi":"10.1177/15910199241270711","DOIUrl":"10.1177/15910199241270711","url":null,"abstract":"<p><strong>Background: </strong>Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question.</p><p><strong>Methods: </strong>SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system.</p><p><strong>Results: </strong>Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86).</p><p><strong>Conclusion: </strong>SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.</p>","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":" ","pages":"15910199241270711"},"PeriodicalIF":1.7,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}