Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2020-08-21
2022-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robotic Endovascular Procedure
Subjects with a clinical indication for endovascular coil and/or stent assisted coiling embolization of cerebral aneurysms will be treated using the CorPath GRX System.
Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Interventions
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Robotic Endovascular Procedure
After providing written informed consent, subjects with cerebral aneurysms may have their aneurysm treated using the CorPath GRX System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one cerebral aneurysm (unruptured) with indication for endovascular treatment; dome to neck ratio \>1.5 or aneurysm neck width \>4.0 mm.
3. The Investigator deems the procedure appropriate for both manual or robotic-assisted endovascular treatment.
4. The conscious subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria
2. The Investigator determines that the subject or the neurovascular anatomy is not suitable for robotic-assisted endovascular treatment.
3. Women who are pregnant.
4. Persons under guardianship or curatorship.
18 Years
ALL
Yes
Sponsors
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Corindus Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michel Piotin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Interventional Neuroradiologisit & Director, Foundation Rothschild
Locations
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Gold Coast University Hospital
Southport, Queensland, Australia
Uniklinikum Salzburg
Salzburg, , Austria
Toronto Western Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, , Canada
Hôpital Pitié-Salpêtrière
Paris, CA, France
CHU Montpellier - Hôpital Gui de Chauliac
Montpellier, , France
Hôpital de la Fondation Rothschild
Paris, , France
Vall d'Hebron University Hospital
Barcelona, , Spain
University Clinical Hospital of Valladolid
Valladolid, , Spain
Inselspital, Universitätsspital Bern
Bern, , Switzerland
Countries
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References
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Lawton MT, Vates GE. Subarachnoid Hemorrhage. N Engl J Med. 2017 Jul 20;377(3):257-266. doi: 10.1056/NEJMcp1605827. No abstract available.
Lantigua H, Ortega-Gutierrez S, Schmidt JM, Lee K, Badjatia N, Agarwal S, Claassen J, Connolly ES, Mayer SA. Subarachnoid hemorrhage: who dies, and why? Crit Care. 2015 Aug 31;19(1):309. doi: 10.1186/s13054-015-1036-0.
Connolly ES Jr, Rabinstein AA, Carhuapoma JR, Derdeyn CP, Dion J, Higashida RT, Hoh BL, Kirkness CJ, Naidech AM, Ogilvy CS, Patel AB, Thompson BG, Vespa P; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Nursing; Council on Cardiovascular Surgery and Anesthesia; Council on Clinical Cardiology. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/american Stroke Association. Stroke. 2012 Jun;43(6):1711-37. doi: 10.1161/STR.0b013e3182587839. Epub 2012 May 3.
Steiner T, Juvela S, Unterberg A, Jung C, Forsting M, Rinkel G; European Stroke Organization. European Stroke Organization guidelines for the management of intracranial aneurysms and subarachnoid haemorrhage. Cerebrovasc Dis. 2013;35(2):93-112. doi: 10.1159/000346087. Epub 2013 Feb 7.
Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
Mendes Pereira V, Rice H, De Villiers L, Sourour N, Clarencon F, Spears J, Tomasello A, Hernandez D, Cancelliere NM, Liu XYE, Nicholson P, Costalat V, Gascou G, Mordasini P, Gralla J, Martinez-Galdamez M, Galvan Fernandez J, Killer-Oberpfalzer M, Liebeskind DS, Turner RD, Blanc R, Piotin M. Evaluation of effectiveness and safety of the CorPath GRX robotic system in endovascular embolization procedures of cerebral aneurysms. J Neurointerv Surg. 2024 Mar 14;16(4):405-411. doi: 10.1136/jnis-2023-020161.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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104-08660
Identifier Type: -
Identifier Source: org_study_id
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