[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medtronic Neurovascular Clinical Affairs\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,69,91],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100285637","the-artisse-intrasaccular-device-is-indicated-for-the-treatment-of-wide-neck-bifurcating-intracranial-aneurysms-ias-100285637",false,"NCT02998229","The Artisse™ Intrasaccular Device is Indicated for the Treatment of Wide-neck Bifurcating Intracranial Aneurysms (IAs).","Artisse™ Intrasaccular Device IDE","ARTISSE","Inclusion Criteria:\n\n1. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent using the Institutional Review Board\u002FEthics Committee (IRB\u002FEC) approved Informed Consent Form (ICF). Health Insurance Portability and Accountability Act (HIPAA)\u002Fdata protection authorization has been provided and signed by the subject or subject's LAR.\n2. Subject is 18-75 years of age at the time of consent.\n3. Subject has a single unruptured or ruptured IA requiring treatment. If the patient has an additional IA, the additional IA must not be deemed to require treatment within 1-year of the index procedure.\n4. The target aneurysm must have the following characteristics:\n\n   1. Saccular morphology\n   2. Located at a bifurcation in the anterior or posterior circulation\n   3. Aneurysm Width appropriate for treatment with the Artisse™ Intrasaccular Device for device sizingper the Instructions for Use.\n   4. Wide-necked, defined as neck size ≥ 4 mm and\u002For a dome-to-neck ratio of ≥ 1 and \\\u003C 2.\n5. If the target aneurysm was acutely ruptured, subject must be neurologically stable with Hunt and Hess Grade of I or II.\n\n   Ruptured IA is defined as showing evidence of SAH attributed to the target aneurysm within the last 30-days (using computed tomography (CT), magnetic resonance imaging (MRI), or lumbar puncture (LP).)\n6. Subject is able to comply with all aspects of the Clinical Investigation Plan (CIP) requirements (e.g., screening, evaluation, treatment, and the post-procedure follow-up schedule).\n7. Subject meets one or more risk factors for IA rupture, such as age, hypertension, cigarette smoking, use of sympathomimetic drugs, Japanese or Finnish ancestry, history of prior aneurysmal subarachnoid hemorrhage (aSAH), familial intracranial aneurysms or SAH, clinical or radiological mass effect, reduced quality of life due to fear of rupture, IA size, location, and morphology, documented growth of IA on serial imaging (or enhanced aneurysm walls on contrast), presence of multiple IAs, and presence of concurrent pathology.\n8. Treating physician has already selected the subject for endovascular treatment of the target aneurysm after considering risk-benefit of clipping vs endovascular treatment\n9. If the subject has an additional IA that was treated previously, the additional IA must have been clinically stable in the past 90 days (i.e. without ongoing adverse events related to the previous treatment).\n\nExclusion Criteria:\n\n1. During treatment planning, it is determined that subject may need an adjunctive implant device in addition to the Artisse™ Intrasaccular Device. (Subjects who need unplanned adjunctive implant devices are not excluded.)\n2. Subject's target aneurysm was previously treated with other devices\u002Fimplants (e.g., coils) or parent artery has a stent or other obstruction that could interfere with the correct placement of the Artisse™ Intrasaccular Device.\n3. Subject has a known active systemic bacterial infection.\n4. Subject has anatomy or physiology considered unsuitable (e.g., vessel anomaly or disease) for endovascular treatment with the Artisse™ Intrasaccular Device by the treating physician.\n5. Subject has a mRS score \\> 2 (i.e., mRS scores of 3 to 5) prior to procedure (in case of unruptured IA) or prior to rupture (in case of ruptured IA).\n6. Subject has an SAH from a non-target aneurysm or any other intracranial hemorrhage within 90 days.\n7. Subject, of child-bearing potential, is pregnant (confirmed with a positive pregnancy test) or plans to become pregnant during the 1 year follow up period after the index procedure.\n8. Subject is enrolled in another device or drug study in which participation could confound study results.\n9. The treating physician determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke) may be compromised by the subject's enrollment.\n10. Subject has a known hypersensitivity, which cannot be medically treated, to any component of the study device, procedural materials, or medications commonly used during the procedure.\n11. Subject is taking anticoagulants (e.g., warfarin) that cannot be discontinued for a minimum of 7 days post-procedure or have a known blood dyscrasia, coagulopathy, or hemoglobinopathy.\n12. Subject has acute or chronic renal failure (unless on dialysis) that would prevent them from undergoing digital subtraction angiography (DSA).\n13. Subject has a life expectancy of less than 5 years due to an illness or condition other than the index IA.","ALL","18 Years","75 Years",{"count":21,"type":22},300,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this study is to assess the safety and effectiveness of the Artisse™ Intrasaccular Device in the treatment of unruptured and ruptured wide-neck bifurcating intracranial aneurysms.",[28],"Intracranial Aneurysm",[30,31,32],"Intracranial aneurysm","Intrasaccular","Artisse","RECRUITING","2026-06-26",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2024-04-16",{"date":41,"type":22},"2032-02",{"name":43,"class":44},"Medtronic Neurovascular Clinical Affairs","INDUSTRY",22,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100562570","nv-psr-inspire-a-pipeline-vantage-post-approval-study-100562570","NCT06604884","NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study","Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA\u002Fdata protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law.\n2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.\n3. Patient is an adult per local law at time of consent.\n\nExclusion Criteria:\n\n1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.\n2. Patient who may be unable to complete the study follow-up.\n3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.\n4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.\n5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug\u002Fdevice study that may confound the study results.","22 Years",{"count":55,"type":22},118,"5 Years","OBSERVATIONAL","The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) (\"Pipeline™ Vantage PAS\") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ (\"Pipeline™ Vantage Device\") in a post approval setting.",[28],"2026-06-22",{"date":62,"type":37},"2026-06-23",{"date":64,"type":37},"2025-12-12",{"date":66,"type":22},"2033-09",{"name":43,"class":44},7,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":78,"studyType":57,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100641607","real-world-clinical-evaulation-of-medtronic-neurovascular-products-for-acute-ischemic-stroke-recanova-registry-100641607","NCT07599904","REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)","RECANOVA","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements.\n2. Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device\\* during treatment for acute ischemic stroke.\n3. Participant is 18 years of age or older.\n\nExclusion Criteria:\n\n1. Participant who may be unable to complete follow-up within the registry.\n2. Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.\n3. Participant is currently enrolled in, or plans to enroll in, any concurrent drug\u002Fdevice study that may confound the study results based on Principal Investigator's discretion.",{"count":77,"type":22},1500,"90 Days","Post-Market Registry",[81],"Acute Ischemic Stroke","2026-06-16",{"date":84,"type":37},"2026-06-18",{"date":86,"type":22},"2026-06",{"date":88,"type":22},"2031-07",{"name":43,"class":44},1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":99,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100284863","neurovascular-product-surveillance-registry-100284863","NCT02988128","Neurovascular Product Surveillance Registry","NeuroVascular Product Surveillance Registry (PSR) Platform","INSPIRE","For MDT16056 and MDT17077\n\nInclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements\n* Patient has, or is intended to receive or be treated with, an eligible Medtronic product\n* Patient is consented within the enrollment window of the therapy received, as applicable\n* Patient is at least 18 years of age at time of enrollment.\n\nExclusion Criteria:\n\n* Patient who is, or is expected to be inaccessible for follow-up\n* Patient with exclusion criteria required by local law\n* Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study that may confound results\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.\n\nFor MDT24028 and MDT22032:\n\nGeneral Inclusion Criteria:\n\n* Patient or legally authorized representative (LAR) provides authorization and\u002For consent per institution and geographical requirements.\n* Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.\n* Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template\n\nGeneral Exclusion Criteria:\n\n* Patient who may be unable to complete the study follow-up\n* Patient with any contraindications per the applicable Instructions for Use document\n* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study\n* Patient is currently enrolled in, or plans to enroll in, any concurrent drug\u002Fdevice study that may confound the study results.\n\nAdditional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.",{"count":100,"type":22},4000,"Post market surveillance registry",[28,103],"Stroke, Ischemic",[105,106,107,108,109,110,111,112,113,114],"Embolization Device","Flow Diverter","Intrasaccular device","Vascular Reconstruction Device","Ruptured Intracranial Aneurysm","Unruptured Intracranial Aneurysm","Large Vessel Occlusion","Stent Retriever","Aspiration Catheter","Revascularization Device","2026-05-31",{"date":117,"type":37},"2026-06-02",{"date":119,"type":37},"2016-12",{"date":121,"type":22},"2032-08",{"name":43,"class":44},99,""]