Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS
NCT ID: NCT05403593
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2021-12-15
2024-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Participants with Intracranial Stenosis
Patients with Intracranial Stenosis who undergo Mechanical Thrombectomy will be added to the registry given they meet the age inclusion criteria.
No Intervention
No intervention, prospective data collection
Interventions
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No Intervention
No intervention, prospective data collection
Eligibility Criteria
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Inclusion Criteria
* AND have intracranial stenosis
* Patients aged 18-90 years
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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University of Göttingen
OTHER
Thomas Jefferson University
OTHER
University of Miami
OTHER
University of Basel
OTHER
University of Tennessee
OTHER
Wake Forest University Health Sciences
OTHER
Emory University
OTHER
The University of Texas Health Science Center at San Antonio
OTHER
University of Iowa
OTHER
Indiana University
OTHER
University of Chicago
OTHER
Careggi Hospital
OTHER
Massachusetts General Hospital
OTHER
Imam Abdulrahman Bin Faisal University
OTHER
Brown University
OTHER
Yale University
OTHER
Sutter Health
OTHER
Centro Hospitalar de Lisboa Central
OTHER
HCA Houston Healthcare Kingwood
UNKNOWN
advocate christ medical center
UNKNOWN
Medical University of South Carolina
OTHER
Responsible Party
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Sami Al Kasab
MD
Principal Investigators
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Sami Al Kasab, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Yale New Haven Hospital
New Haven, Connecticut, United States
Univeristy of Miami Health System
Miami, Florida, United States
Emory Univeristy Hospital
Atlanta, Georgia, United States
Univeristy of Chicago Medicine
Chicago, Illinois, United States
Advocate Aurora Health
Oak Lawn, Illinois, United States
Indiana Health Univeristy Hospital
Indianapolis, Indiana, United States
Univeristy of Iowa Hospital
Iowa City, Iowa, United States
Massachuestts General Hospital
Boston, Massachusetts, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
Univeristy of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Universitätsmedizin Göttingen
Göttingen, Germany, Germany
Careggi Universtiy Hospital
Florence, Florence, Italy
Nova University Lisbon
Lisbon, Portugal, Portugal
Imam Abdulrahman Alfaisal University
Dammam, Dammam, Saudi Arabia
Universitätsspital Basel
Basel, Basel, Switzerland
Countries
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References
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Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
Khatri P, Abruzzo T, Yeatts SD, Nichols C, Broderick JP, Tomsick TA; IMS I and II Investigators. Good clinical outcome after ischemic stroke with successful revascularization is time-dependent. Neurology. 2009 Sep 29;73(13):1066-72. doi: 10.1212/WNL.0b013e3181b9c847.
Kleine JF, Wunderlich S, Zimmer C, Kaesmacher J. Time to redefine success? TICI 3 versus TICI 2b recanalization in middle cerebral artery occlusion treated with thrombectomy. J Neurointerv Surg. 2017 Feb;9(2):117-121. doi: 10.1136/neurintsurg-2015-012218. Epub 2016 Feb 17.
Zaidat OO, Castonguay AC, Nogueira RG, Haussen DC, English JD, Satti SR, Chen J, Farid H, Borders C, Veznedaroglu E, Binning MJ, Puri A, Vora NA, Budzik RF, Dabus G, Linfante I, Janardhan V, Alshekhlee A, Abraham MG, Edgell R, Taqi MA, Khoury RE, Mokin M, Majjhoo AQ, Kabbani MR, Froehler MT, Finch I, Ansari SA, Novakovic R, Nguyen TN. TREVO stent-retriever mechanical thrombectomy for acute ischemic stroke secondary to large vessel occlusion registry. J Neurointerv Surg. 2018 Jun;10(6):516-524. doi: 10.1136/neurintsurg-2017-013328. Epub 2017 Sep 29.
Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
Zaidat OO, Mueller-Kronast NH, Hassan AE, Haussen DC, Jadhav AP, Froehler MT, Jahan R, Ali Aziz-Sultan M, Klucznik RP, Saver JL, Hellinger FR Jr, Yavagal DR, Yao TL, Gupta R, Martin CO, Bozorgchami H, Kaushal R, Nogueira RG, Gandhi RH, Peterson EC, Dashti S, Given CA 2nd, Mehta BP, Deshmukh V, Starkman S, Linfante I, McPherson SH, Kvamme P, Grobelny TJ, Hussain MS, Thacker I, Vora N, Chen PR, Monteith SJ, Ecker RD, Schirmer CM, Sauvageau E, Chebl AB, Derdeyn CP, Maidan L, Badruddin A, Siddiqui AH, Dumont TM, Alhajeri A, Taqi MA, Asi K, Carpenter J, Boulos A, Jindal G, Puri AS, Chitale R, Deshaies EM, Robinson D, Kallmes DF, Baxter BW, Jumaa M, Sunenshine P, Majjhoo A, English JD, Suzuki S, Fessler RD, Delgado-Almandoz J, Martin JC, Liebeskind DS; STRATIS Investigators. Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry. Stroke. 2019 Mar;50(3):697-704. doi: 10.1161/STROKEAHA.118.021126.
Kaesmacher J, Gralla J, Mosimann PJ, Zibold F, Heldner MR, Piechowiak E, Dobrocky T, Arnold M, Fischer U, Mordasini P. Reasons for Reperfusion Failures in Stent-Retriever-Based Thrombectomy: Registry Analysis and Proposal of a Classification System. AJNR Am J Neuroradiol. 2018 Oct;39(10):1848-1853. doi: 10.3174/ajnr.A5759. Epub 2018 Aug 30.
Kang DH, Kim YW, Hwang YH, Park SP, Kim YS, Baik SK. Instant reocclusion following mechanical thrombectomy of in situ thromboocclusion and the role of low-dose intra-arterial tirofiban. Cerebrovasc Dis. 2014;37(5):350-5. doi: 10.1159/000362435. Epub 2014 Jun 13.
Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
Zaidat OO, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Megerian JT, Lesko J, Pitzer P, Ramos J, Castonguay AC, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Effect of a balloon-expandable intracranial stent vs medical therapy on risk of stroke in patients with symptomatic intracranial stenosis: the VISSIT randomized clinical trial. JAMA. 2015 Mar 24-31;313(12):1240-8. doi: 10.1001/jama.2015.1693.
Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
Yu SC, Cheng HK, Cheng PW, Lui WM, Leung KM, Tan CB, Pang KY, Wong GK, Cheung YL, Lee R, Wong YC, Wong CK, Kwok JC; Hong Kong Society of Interventional and Therapeutic Neuroradiology. Angioplasty and stenting for intracranial atherosclerotic stenosis: position statement of the Hong Kong Society of Interventional and Therapeutic Neuroradiology. Hong Kong Med J. 2013 Feb;19(1):69-73.
Al Kasab S, Almallouhi E, Jumaa M, Inoa V, Capasso F, Nahhas M, Starke RM, Fragata I, Bender M, Moldovan K, Yaghi S, Maier I, Grossberg JA, Jabbour P, Psychogios M, Samaniego EA, Burkhardt JK, Jankowitz B, Abdalkader M, Hassan AE, Altschul D, Mascitelli J, Regenhardt RW, Wolfe S, Ezzeldin M, Limaye K, Grandhi R, Al Jehani H, Niazi M, Goyal N, Tjoumakaris S, Alawieh A, Abdelsalam A, Guada L, Ntoulias N, El-Ghawanmeh R, Batra V, Choi A, Zohdy YM, Nguyen S, Essibayi MA, El Naamani K, Koo A, Almekhlafi M, Raz E, Miller S, Mierzwa A, Zaidi S, Gudino AS, Alsarah A, Azeem HM, Mattingly TK, Schartz DA, Nelson A, Pinheiro C, Spiotta AM, Kicielinski K, Lena J, Lajthia O, Hubbard Z, Zaidat OO, Derdeyn CP, Klein P, Nguyen TN, de Havenon A. Outcomes of Adjunct Emergent Stenting Versus Mechanical Thrombectomy Alone: The RESCUE-ICAS Registry. Stroke. 2025 Feb;56(2):390-400. doi: 10.1161/STROKEAHA.124.049038. Epub 2024 Nov 22.
Other Identifiers
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Pro00115854
Identifier Type: -
Identifier Source: org_study_id
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