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Intracranial StenosisRESCUE-ICASNCT05403593

Registry of Emergent Large VeSsel OCclUsion DuE to IntraCranial AtherosclerosiS

An observational study of Intracranial Stenosis and Large Vessel Occlusion, run by Medical University of South Carolina at 19 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 years
How many people
600 participants
Where
19 sitesin 6 countries
Study dates
15 Dec 2021to 14 Jun 2024
How long will I take part?
90 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects aged 18-90 years will be identified once they undergo mechanical thrombectomy and identified as having intracranial stenosis as the etiology for large vessel occlusion.

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

19 sites in 6 countries.

19 sites in 6 countries

United States14 sites
  • Emory Univeristy Hospital

    Atlanta, Georgia, 30322

  • Massachuestts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Univeristy of Chicago Medicine

    Chicago, Illinois, 60637

  • Indiana Health Univeristy Hospital

    Indianapolis, Indiana, 46202

  • Univeristy of Iowa Hospital

    Iowa City, Iowa, 52242

  • The University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Univeristy of Miami Health System

    Miami, Florida, 33136

  • Yale New Haven Hospital

    New Haven, Connecticut, 06508

  • Advocate Aurora Health

    Oak Lawn, Illinois, 60453

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Brown University

    Providence, Rhode Island, 02903

  • Univeristy of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

Germany1 site
  • Universitätsmedizin Göttingen

    Göttingen, Germany, 37099

Other trials in Germany

Italy1 site
  • Careggi Universtiy Hospital

    Florence, Florence, 50134

Other trials in Italy

Portugal1 site
  • Nova University Lisbon

    Lisbon, Portugal, 1169-056

Other trials in Portugal

Saudi Arabia1 site
  • Imam Abdulrahman Alfaisal University

    Dammam, Dammam, 34212

Other trials in Saudi Arabia

Switzerland1 site
  • Universitätsspital Basel

    Basel, Basel, 4031

Other trials in Switzerland

About this study

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.

Being tested
No Intervention
Keywords
Intracranial Stenosis, Large Vessel Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

    No intervention, prospective data collection

Study groups in NCT05403593
Study groupRoleWhat they receive
Participants with Intracranial StenosisPatients with Intracranial Stenosis who undergo Mechanical Thrombectomy will be added to the registry given they meet the age inclusion criteria.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified Rankin score

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

    Measured: pre-stroke

  2. modified Rankin score

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

    Measured: 7 days

  3. modified Rankin score

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

    Measured: admission

  4. modified Rankin score

    standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score.

    Measured: 3 months

  5. Mortality

    Death at 90 days post intervention

    Measured: 90 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start15 Dec 2021
  3. Primary completion5 Mar 2024
  4. Study completion14 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
600 participants (actual)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403593
Sponsor's protocol ID
Pro00115854
Acronym
RESCUE-ICAS
Status last verified
Mar 2024
First submitted
24 May 2022
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All data will be de-identified

Publications

  • 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.

    PubMed 31662037
  • 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.

    PubMed 19786699
  • 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.

    PubMed 26888952
  • 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.

    PubMed 28963367
  • 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.

    PubMed 26898852
  • 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.

    PubMed 30776994
  • 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.

    PubMed 30166434
  • 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.

    PubMed 24941966
  • 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.

    PubMed 21899409
  • 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.

    PubMed 25803346
  • 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.

    PubMed 15800226
  • 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.

    PubMed 23378358
  • Nguyen S, de Havenon A, Almallouhi E, Jumaa MA, Inoa V, Capasso F, Nahhas MI, Starke RM, Fragata I, Bender MT, Moldovan K, Yaghi S, Maier I, Grossberg JA, Jabbour PM, Psychogios MN, Samaniego EA, Burkhardt JK, Jankowitz BT, Abdalkader M, Hassan AE, Altschul DJ, Mascitelli J, Regenhardt RW, Wolfe SQ, Ezzeldin M, Limaye K, Al-Jehani H, Niazi H, Goyal N, Tjoumakaris SI, Alawieh AM, Almekhlafi M, Raz E, Mierzwa A, Zaidi SF, Spiotta AM, Kicielinski KP, Lena J, Hubbard Z, Zaidat OO, Derdeyn CP, Nguyen TN, Al Kasab S, Grandhi R. Effect of Acute Intracranial Stenting in Patients With Successful Reperfusion Following Large-Vessel Occlusion Secondary to Intracranial Atherosclerosis: Secondary Analyses of the RESCUE-ICAS Study. Stroke Vasc Interv Neurol. 2026 Jan 22;6(2):e001841. doi: 10.1161/SVIN.125.001841. eCollection 2026 Mar.

    PubMed 41815302
  • 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.

    PubMed 39576761

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Stenosis and Large Vessel Occlusion, run by Medical University of South Carolina at 19 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany, Italy, Portugal, Saudi Arabia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin score (time frame: pre-stroke). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403593, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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