Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS

NCT ID: NCT05403593

Last Updated: 2024-09-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-15

Study Completion Date

2024-06-14

Brief Summary

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The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.

Detailed Description

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Conditions

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Intracranial Stenosis Large Vessel Occlusion Mechanical Thrombectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

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

Intervention Type OTHER

No intervention, prospective data collection

Interventions

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No Intervention

No intervention, prospective data collection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing mechanical thrombectomy
* AND have intracranial stenosis
* Patients aged 18-90 years

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Göttingen

OTHER

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role collaborator

University of Tennessee

OTHER

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role collaborator

Careggi Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Sutter Health

OTHER

Sponsor Role collaborator

Centro Hospitalar de Lisboa Central

OTHER

Sponsor Role collaborator

HCA Houston Healthcare Kingwood

UNKNOWN

Sponsor Role collaborator

advocate christ medical center

UNKNOWN

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Sami Al Kasab

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Univeristy of Miami Health System

Miami, Florida, United States

Site Status

Emory Univeristy Hospital

Atlanta, Georgia, United States

Site Status

Univeristy of Chicago Medicine

Chicago, Illinois, United States

Site Status

Advocate Aurora Health

Oak Lawn, Illinois, United States

Site Status

Indiana Health Univeristy Hospital

Indianapolis, Indiana, United States

Site Status

Univeristy of Iowa Hospital

Iowa City, Iowa, United States

Site Status

Massachuestts General Hospital

Boston, Massachusetts, United States

Site Status

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

The University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Univeristy of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Universitätsmedizin Göttingen

Göttingen, Germany, Germany

Site Status

Careggi Universtiy Hospital

Florence, Florence, Italy

Site Status

Nova University Lisbon

Lisbon, Portugal, Portugal

Site Status

Imam Abdulrahman Alfaisal University

Dammam, Dammam, Saudi Arabia

Site Status

Universitätsspital Basel

Basel, Basel, Switzerland

Site Status

Countries

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United States Germany Italy Portugal Saudi Arabia Switzerland

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 30776994 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30166434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24941966 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 15800226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23378358 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39576761 (View on PubMed)

Other Identifiers

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Pro00115854

Identifier Type: -

Identifier Source: org_study_id

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