[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583158":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":203,"collaborators":20,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":207,"sex":213,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":20,"studyType":219,"phases":220,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":240},{"fullName":5,"class":6},"Stryker Neurovascular","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surpass Elite with Guardian Flow Diverter","EXPERIMENTAL","This is a prospective single arm study in which all subjects who present for Surpass Elite with Guardian flow diverter implantation, provide informed consent, and meet inclusion\u002Fexclusion criteria may receive treatment.",[13],"Device: Surpass Elite with Guardian Flow Diverter System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Surpass Elite with Guardian Flow Diverter System","The Surpass Elite with Guardian Flow Diverter System is indicated for use in the endovascular treatment of adults (age 18 or above) with unruptured wide-neck saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 3.0 millimeter (mm) and ≤ 6.0 mm and located on the Internal Carotid Artery (ICA) or its branches.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Stacy Phung","CONTACT","678-469-2428","stacy.phung@stryker.com",{"name":28,"role":24,"phone":20,"phoneExt":20,"email":29},"John Strohmeyer","john.strohmeyer@stryker.com",[31,53,70,86,103,120,137,153,169,186],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Carondelet St. Joseph's Hospital","RECRUITING","Tucson","Arizona","85711","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-110.92648,32.22174,{"lat":43,"lon":42},[46,50],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Rachael Taoka","520-873-1592","Rachael2.taoka@tenethealth.com",{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Alexander Coon, MD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":33,"city":55,"state":56,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"University of California Davis Health","Davis","California","95616",{"type":40,"coordinates":59},[60,61],-121.74052,38.54491,{"lat":61,"lon":60},[64,68],{"name":65,"role":24,"phone":66,"phoneExt":20,"email":67},"Savina Nguyen","916-551-3234","savnguyen@ucdavis.edu",{"name":69,"role":52,"phone":20,"phoneExt":20,"email":20},"Ben Waldau, MD, MAS, FAANS, FACS",{"facility":71,"status":33,"city":72,"state":56,"zip":73,"country":37,"countryCode":38,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Stanford University School of Medicine","Palo Alto","94304",{"type":40,"coordinates":75},[76,77],-122.14302,37.44188,{"lat":77,"lon":76},[80,84],{"name":81,"role":24,"phone":82,"phoneExt":20,"email":83},"Banu Priya Rajasekaran","650-304-6402","bpriya@stanford.edu",{"name":85,"role":52,"phone":20,"phoneExt":20,"email":20},"Robert Dodd, MD",{"facility":87,"status":33,"city":88,"state":89,"zip":90,"country":37,"countryCode":38,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Lyerly Neurosurgery, an Affiliate of Baptist","Jacksonville","Florida","32207",{"type":40,"coordinates":92},[93,94],-81.65565,30.33218,{"lat":94,"lon":93},[97,101],{"name":98,"role":24,"phone":99,"phoneExt":20,"email":100},"Karen Yesensky","904-202-7091","karen.yesensky@bmcjax.com",{"name":102,"role":52,"phone":20,"phoneExt":20,"email":20},"Ricardo Hanel, MD",{"facility":104,"status":33,"city":105,"state":106,"zip":107,"country":37,"countryCode":38,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":40,"coordinates":109},[110,111],-94.62746,39.11417,{"lat":111,"lon":110},[114,118],{"name":115,"role":24,"phone":116,"phoneExt":20,"email":117},"Max Hardenbrook","913-588-6191","mhardenbrook@kumc.edu",{"name":119,"role":52,"phone":20,"phoneExt":20,"email":20},"Koji Ebersole, MD",{"facility":121,"status":33,"city":122,"state":123,"zip":124,"country":37,"countryCode":38,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Lahey Hospital and Medical Center","Burlington","Massachusetts","01803",{"type":40,"coordinates":126},[127,128],-71.19561,42.50482,{"lat":128,"lon":127},[131,135],{"name":132,"role":24,"phone":133,"phoneExt":20,"email":134},"Sandy Alvarez","786-580-0186","Sandy.L.Alvarez@lahey.org",{"name":136,"role":52,"phone":20,"phoneExt":20,"email":20},"Emanuele Orru', MD",{"facility":138,"status":33,"city":139,"state":139,"zip":140,"country":37,"countryCode":38,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Mount Sinai Health System","New York","10029",{"type":40,"coordinates":142},[143,144],-74.00597,40.71427,{"lat":144,"lon":143},[147,151],{"name":148,"role":24,"phone":149,"phoneExt":20,"email":150},"Emily Svendsen","212-241-3238","emily.svendsen@mountsinai.org",{"name":152,"role":52,"phone":20,"phoneExt":20,"email":20},"Reade DeLeacy, MD",{"facility":154,"status":33,"city":155,"state":139,"zip":156,"country":37,"countryCode":38,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Stony Brook University Hospital","Stony Brook","11794",{"type":40,"coordinates":158},[159,160],-73.14094,40.92565,{"lat":160,"lon":159},[163,167],{"name":164,"role":24,"phone":165,"phoneExt":20,"email":166},"Marlene Baumeister","631-444-1610","marlene.baumeister@stonybrookmedicine.edu",{"name":168,"role":52,"phone":20,"phoneExt":20,"email":20},"David Fiorella, MD",{"facility":170,"status":33,"city":171,"state":172,"zip":173,"country":37,"countryCode":38,"cosmosGeoPoint":174,"geoPoint":178,"contacts":179},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":40,"coordinates":175},[176,177],-81.69541,41.4995,{"lat":177,"lon":176},[180,184],{"name":181,"role":24,"phone":182,"phoneExt":20,"email":183},"Barmen Joyce","216 445-5869","BARMENJ2@ccf.org",{"name":185,"role":52,"phone":20,"phoneExt":20,"email":20},"Mark Bain, MD",{"facility":187,"status":33,"city":188,"state":189,"zip":190,"country":37,"countryCode":38,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Oregon Health & Science University","Portland","Oregon","97239",{"type":40,"coordinates":192},[193,194],-122.67621,45.52345,{"lat":194,"lon":193},[197,201],{"name":198,"role":24,"phone":199,"phoneExt":20,"email":200},"Emilie Nagle","503-418-1722","bode@ohsu.edu",{"name":202,"role":52,"phone":20,"phoneExt":20,"email":20},"Ryan Priest, MD",{"type":204,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100583158","safety-and-efficacy-of-endovascular-treatment-of-intracranial-aneurysms-with-surpass-elite-with-guardian-flow-diverter-guard-100583158",false,"NCT06872684","Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)","Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter","GUARD","Inclusion Criteria:\n\n1. Age is ≥18 and ≤80 years at the time of consent\n2. Has a single unruptured target intracranial aneurysm (IA) of any size with the following characteristics:\n\n   1. Is located on the internal carotid artery or its branches\n   2. Has a wide neck (wide neck typically defined as neck width ≥ 4 millimeter (mm), or dome to neck ratio ≤ 2.0) or no discernible neck\n   3. Aneurysm is either saccular or fusiform in nature\n3. Has a parent vessel diameter ≥ 3.0 mm to ≤ 6.0 mm at the largest diameter\n4. There is documented risk-benefit of endovascular treatment that outweighs the risks of intracranial aneurysm rupture during the subject's expected lifetime if left untreated.\n\nExclusion Criteria:\n\n1. Has an extradural target aneurysm\n2. Has a target aneurysm in the posterior circulation\n3. Perforator or branch vessel, inclusive of the posterior communicating artery, arises from the target aneurysm body or neck (branches or arteries must arise or connect from the parent vessel separate from the aneurysm or neck to not be excluded from trial)\n4. Has a true bifurcation aneurysm, defined as an aneurysm (saccular or non-saccular) located at a point of vessel bifurcation\n5. Has vessel characteristics, such as severe tortuosity (cavernous Internal Carotid Artery (cICA) Type IV1), stenosis (\\>70%), or morphology that would preclude safe endovascular access or proper deployment of the trial device to the target aneurysm\n6. Received previous treatment for the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device\n7. Has a medical contraindication to trial or procedure related antiplatelet medications (aspirin, clopidogrel\u002FPlavix, ticagrelor, and heparin), local or general anesthesia, or life-threatening allergy to contrast dye\n8. Has a known severe allergy to nickel, chromium cobalt, tungsten, or platinum\n9. Patients with heparin hypersensitivity, including patients with a previous incident of Heparin-Induced Thrombocytopenia (HIT).\n10. Modified Rankin Score (mRS) assessment is ≥ 3 at pre-procedure exam\n11. Presence of unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days prior to the index procedure)\n12. Subarachnoid hemorrhage occurred within 30 days prior to the index procedure\n13. Major surgery (including previous intracranial implant) either occurred within 30 days prior to the index procedure date or is planned to occur within 120 days following the index procedure date\n14. Has more than one intracranial aneurysm (IA) that requires treatment within 12 months after the index procedure\n15. Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 84 days prior to treatment date\n16. Chronic anticoagulation therapy is ongoing or known coagulopathy exists\n17. Has atrial fibrillation with or without pacemaker.\n18. Has other known serious concurrent medical conditions such as cardiovascular disease (including recent myocardial infarction \\[\\\u003C12 weeks\\], symptomatic congestive heart failure, or carotid stenosis), kidney failure (\\>2.0 mg\u002Fdl serum creatinine), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, terminal cancer, vasculitis, high risk of ischemic stroke or recent stroke\n19. Has acute life-threatening illness (e.g., acute kidney or heart failure) other than the neurological disease to be treated in this trial\n20. Evidence of active infection at the time of treatment\n21. Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)\n22. Unable to comply with the trial follow up requirements due to conditions such as dementia or psychiatric problems, active substance abuse, or history of non-compliance with medical advice, as determined by the investigator\n23. Pregnant or breast- feeding women or women who wish to become pregnant during the length of trial participation\n24. Presence of intracranial mass (tumor, except meningioma, abscess, or other infection), non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm\n25. Enrollment in another study involving an investigational product that could confound the outcomes of this trial","ALL","18 Years","80 Years",{"count":217,"type":218},183,"ESTIMATED","INTERVENTIONAL",[221],"NA","The objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.",[224,225],"Aneurysm","Aneurysm, Intracranial",[227,228,229,230],"Saccular Aneurysm","Fusiform Aneurysm","Unruptured Aneurysm","Flow Diverter","2026-04-06",{"date":233,"type":234},"2026-04-08","ACTUAL",{"date":236,"type":234},"2025-06-20",{"date":238,"type":218},"2031-01-31",{"name":5,"class":6},10]