Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS

Large Vessel Occlusion Clinical Trial

— RESCUE-ICAS  

Official title:

Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05403593
• Other study ID #: Pro00115854
• Status: Active, not recruiting
• Start date: December 15, 2021
• Est. completion date: June 14, 2024

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: June 14, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients undergoing mechanical thrombectomy

• AND have intracranial stenosis

• Patients aged 18-90 years

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Stenosis
• Large Vessel Occlusion
• Mechanical Thrombectomy

Intervention

Other:
• No Intervention
No intervention, prospective data collection

Locations

Country	Name	City	State
Germany	Universitätsmedizin Göttingen	Göttingen
Italy	Careggi Universtiy Hospital	Florence
Portugal	Nova University Lisbon	LIsbon
Saudi Arabia	Imam Abdulrahman Alfaisal University	Dammam
Switzerland	Universitätsspital Basel	Basel
United States	Emory Univeristy Hospital	Atlanta	Georgia
United States	Massachuestts General Hospital	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Univeristy of Chicago Medicine	Chicago	Illinois
United States	Indiana Health Univeristy Hospital	Indianapolis	Indiana
United States	Univeristy of Iowa Hospital	Iowa City	Iowa
United States	The University of Tennessee Health Science Center	Memphis	Tennessee
United States	Univeristy of Miami Health System	Miami	Florida
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Advocate Aurora Health	Oak Lawn	Illinois
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Brown University	Providence	Rhode Island
United States	Univeristy of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (21)

Lead Sponsor

Collaborator

Medical University of South Carolina

advocate christ medical center, Brown University, Careggi Hospital, Centro Hospitalar de Lisboa Central, Emory University, HCA Houston Healthcare Kingwood, Imam Abdulrahman Bin Faisal University, Indiana University, Massachusetts General Hospital, Sutter Health, The University of Texas Health Science Center at San Antonio, Thomas Jefferson University, University of Basel, University of Chicago, University of Göttingen, University of Iowa, University of Miami, University of Tennessee, Wake Forest University Health Sciences, Yale University

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Portugal,  Saudi Arabia,  Switzerland, 

References & Publications (12)

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. Erratum In: N Engl J Med. 2012 Jul 5;367(1):93. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2019 Dec;50(12):e440-e441. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-stroke
Primary	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.	7 days
Primary	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.	admission
Primary	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.	3 months
Primary	Mortality	Death at 90 days post intervention	90 day