CT (Computerized Tomography) for Late EndovasculAr Reperfusion

NCT04096248 | Completed

• 1 other identifier: H-37843
• Study Type: observational
• Target: 2,790
• Locations: 10 countries
• Sites: 19

Brief Summary

The objective of this multicenter, retrospective, cross-sectional, chart review study is to compare outcomes (disability, complications and mortality) of patients with large vessel occlusion stroke presenting at late time window selected by either Non-Contrast CT (NCCT) only, advanced imaging with CTP (Computed Tomography Perfusion), MRI (Magnetic Resonance Imaging), or medical management. Boston Medical Center (BMC) will serve as the main data coordinating site. Fifteen additional sites will seek local IRB approval or ethics approval. The aggregated de-identified data will be analyzed comparing types of interventions and outcomes by type of imaging or medical management.

Conditions

Stroke, Cardiovascular

Keywords

Large vessel occlusion; CT [Computed Tomography]; CTP [Computed Tomography (CT) Perfusion]; Modified Rankin score; ASPECTS (Alberta Stroke Program Early CT Score)

Outcome Measures

Primary Outcomes (1)

• Change in patients' disability based on a Modified Rankin Scale

  The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0 to 5. Lower scores correlate with less disability/dependence.

  baseline, 90 days

Secondary Outcomes (2)

• Intracranial hemorrhage incidence

  90 days

• Mortality rate

  90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective chart abstraction will be done on consecutive patients treated with a large vessel occlusion stroke who meet the inclusion and none of the exclusion criteria between January 1, 2014 and May 1, 2022.

You may qualify if:

• Patients presenting 6-24 hours from last known well with large vessel occlusion stroke
• ASPECTS score 5 or greater from last known well
• January 1, 2014 to May 1, 2022

You may not qualify if:

• Time last seen well to treatment \<6 hours from last known well

Sponsors & Collaborators

• Boston Medical Center: lead
• Medtronic: collaborator
• Society of Vascular and Interventional Neurology: collaborator

Study Sites (19)

Grady Health; Marcus Stroke & Neuroscience Center

Atlanta, Georgia, 30303, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

Upstate University Hospital

Syracuse, New York, 13202, United States

Location

University of Toledo

Toledo, Ohio, 43606, United States

Location

Mercy Health Neuroscience Institute

Toledo, Ohio, 43608, United States

Location

UZ Leuven

Leuven, Belgium

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 0C1, Canada

Location

Helsinki University Hospital

Helsinki, Finland

Location

Universite de Lille

Lille, France

Location

University Hospital Carl Gustav Carus

Dresden, Germany

Location

Heidelberg University

Heidelberg, Germany

Location

National Cerebral and Cardiovascular Center

Osaka, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Japan

Location

Hospital de Egas Moniz

Lisbon, Portugal

Location

Val D'Hebron

Barcelona, Spain

Location

Bern University Hospital

Bern, Switzerland

Location

Lausanne University Hospital

Lausanne, Switzerland

Location

Related Publications (11)

• Nguyen TN, Abdalkader M, Nagel S, Qureshi MM, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi S, Olive-Gadea M, Henon H, Mohlenbruch MA, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Seker F, Farooqui M, Salazar-Marioni S, Kuhn AL, Kaliaev A, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Kareem SA, Sathya A, Klein P, Kassem MW, Ringleb PA, Cordonnier C, Gralla J, Fischer U, Michel P, Jovin TG, Raymond J, Zaidat OO, Nogueira RG. Noncontrast Computed Tomography vs Computed Tomography Perfusion or Magnetic Resonance Imaging Selection in Late Presentation of Stroke With Large-Vessel Occlusion. JAMA Neurol. 2022 Jan 1;79(1):22-31. doi: 10.1001/jamaneurol.2021.4082.

  PMID: 34747975 RESULT

• Seker F, Qureshi MM, Mohlenbruch MA, Nogueira RG, Abdalkader M, Ribo M, Caparros F, Haussen DC, Mohammaden MH, Sheth SA, Ortega-Gutierrez S, Siegler JE, Zaidi SF, Olive-Gadea M, Henon H, Castonguay AC, Nannoni S, Kaesmacher J, Puri AS, Farooqui M, Salazar-Marioni S, Kuhn AL, Kiley NL, Farzin B, Boisseau W, Masoud HE, Lopez CY, Rana A, Abdul Kareem S, Sathya A, Klein P, Kassem MW, Cordonnier C, Gralla J, Fischer U, Michel P, Strambo D, Jovin TG, Raymond J, Zaidat OO, Ringleb PA, Nguyen TN, Nagel S. Reperfusion Without Functional Independence in Late Presentation of Stroke With Large Vessel Occlusion. Stroke. 2022 Dec;53(12):3594-3604. doi: 10.1161/STROKEAHA.122.039476. Epub 2022 Oct 14.

  PMID: 36252092 RESULT

• Siegler JE, Qureshi MM, Nogueira RG, Tanaka K, Nagel S, Michel P, Vigilante N, Ribo M, Yamagami H, Yoshimura S, Abdalkader M, Haussen DC, Mohammaden MH, Nannoni S, Mohlenbruch MA, Henon H, Sheth SA, Ortega-Gutierrez S, Olive-Gadea M, Caparros F, Seker F, Zaidi S, Castonguay AC, Uchida K, Sakai N, Puri AS, Farooqui M, Toyoda K, Salazar-Marioni S, Takeuchi M, Farzin B, Masoud HE, Kuhn AL, Rana A, Morimoto M, Shibata M, Nonaka T, Klein P, Sathya A, Kiley NL, Cordonnier C, Strambo D, Demeestere J, Ringleb PA, Roy D, Zaidat OO, Jovin TG, Kaesmacher J, Fischer U, Raymond J, Nguyen TN. Endovascular vs Medical Management for Late Anterior Large Vessel Occlusion With Prestroke Disability: Analysis of CLEAR and RESCUE-Japan. Neurology. 2023 Feb 14;100(7):e751-e763. doi: 10.1212/WNL.0000000000201543. Epub 2022 Nov 4.

  PMID: 36332983 RESULT

• Demeestere J, Qureshi MM, Vandewalle L, Wouters A, Strbian D, Nogueira RG, Nagel S, Yamagami H, Puetz V, Abdalkader M, Haussen DC, Mohammaden MH, Mohlenbruch MA, Olive-Gadea M, Winzer S, Ribo M, Michel P, Marto JP, Tanaka K, Yoshimura S, Martinez-Majander N, Caparros F, Henon H, Tomppo L, Dusart A, Bellante F, Ramos JN, Jesser J, Sheth SA, Ortega-Gutierrez S, Siegler JE, Nannoni S, Kaesmacher J, Dobrocky T, Salazar-Marioni S, Farooqui M, Virtanen P, Ventura R, Zaidi SF, Castonguay AC, Uchida K, Puri AS, Sakai N, Toyoda K, Farzin B, Masoud HE, Klein P, Bui J, Rizzo F, Kaiser DPO, Desfontaines P, Strambo D, Cordonnier C, Lin E, Ringleb PA, Roy D, Zaidat OO, Fischer U, Raymond J, Lemmens R, Nguyen TN. Outcomes of Bridging Intravenous Thrombolysis Versus Endovascular Therapy Alone in Late-Window Acute Ischemic Stroke. Stroke. 2024 Jul;55(7):1767-1775. doi: 10.1161/STROKEAHA.124.046495. Epub 2024 May 15.

  PMID: 38748598 RESULT

• Mujanovic A, Strbian D, Demeestere J, Marto JP, Puetz V, Nogueira RG, Abdalkader M, Nagel S, Raymond J, Ribo M, Michel P, Yoshimura S, Zaidat OO, Winzer S, Ortega-Gutierrez S, Sheth SA, Siegler JE, Dusart A, Haussen DC, Henon H, Serrallach BL, Mohammaden MH, Mohlenbruch MA, Olive-Gadea M, Puri AS, Sakai N, Klein P, Tomppo L, Caparros F, Ramos JN, Jumaa M, Zaidi S, Dobrocky T, Martinez-Majander N, Nannoni S, Bellante F, Rodriguez-Calienes A, Salazar-Marioni S, Virtanen P, Kaiser DP, Ventura R, Jesser J, Castonguay AC, Qureshi MM, Masoud HE, Galecio-Castillo M, Requena M, Lauha R, Hu W, Lin E, Miao Z, Roy D, Yamagami H, Seiffge DJ, Strambo D, Ringleb PA, Lemmens R, Fischer U, Nguyen TN, Kaesmacher J. Safety and clinical outcomes of endovascular therapy versus medical management in late presentation of large ischemic stroke. Eur Stroke J. 2024 Dec;9(4):907-917. doi: 10.1177/23969873241249406. Epub 2024 May 17.

  PMID: 38757713 RESULT

• Nguyen TN, Nogueira RG, Qureshi MM, Nagel S, Raymond J, Abdalkader M, Demeestere J, Marto JP, Sheth SA, Puetz V, Dusart A, Michel P, Ribo M, Zaidat OO, Siegler JE, Haussen DC, Strbian D, Henon H, Mohammaden MH, Mohlenbruch MA, Olive-Gadea M, Puri AS, Winzer S, Kaesmacher J, Klein P, Tomppo L, Caparros F, Ramos JN, Jumaa MA, Zaidi SF, Martinez-Majander N, Nannoni S, Vandewalle L, Bellante F, Farooqui M, Salazar-Marioni S, Virtanen P, Kaiser DPO, Wouters A, Ventura R, Jesser J, Mujanovic A, Shu L, Castonguay AC, Mansoor Z, Qiu Z, Masoud HE, Requena M, Peltola E, Hu W, Lin E, Tanaka K, Cordonnier C, Roy D, Yaghi S, Strambo D, Yamagami H, Fischer U, Jovin TG, Lemmens R, Ringleb PA, Ortega-Gutierrez S. Noncontrast CT Selected Thrombectomy vs Medical Management for Late-Window Anterior Large Vessel Occlusion. Neurology. 2024 May 28;102(10):e209324. doi: 10.1212/WNL.0000000000209324. Epub 2024 May 6.

  PMID: 38709999 RESULT

• Abdalkader M, Ning S, Qureshi MM, Haussen DC, Strbian D, Nagel S, Demeestere J, Puetz V, Mohammaden MH, Olive Gadea M, Winzer S, Yamagami H, Tanaka K, Marto JP, Tomppo L, Henon H, Sheth SA, Ortega-Gutierrez S, Martinez-Majander N, Caparros F, Lemmens R, Dusart A, Bellante F, Zaidi SF, Siegler JE, Nannoni S, Kaesmacher J, Dobrocky T, Farooqui M, Salazar-Marioni S, Virtanen P, Vandewalle L, Wouters A, Jesser J, Ventura R, Castonguay AC, Uchida K, Puri AS, Masoud HE, Klein P, Mansoor Z, Bui J, Kang M, Mujanovic A, Rizzo F, Kokkonen T, Ramos JN, Strambo D, Michel P, Mohlenbruch MA, Lin E, Kaiser DPO, Yoshimura S, Sakai N, Cordonnier C, Ringleb PA, Roy D, Zaidat OO, Fischer U, Ribo M, Raymond J, Nogueira RG, Nguyen TN. Sex Differences in Outcomes of Late-Window Endovascular Stroke Therapy. Stroke. 2024 Feb;55(2):278-287. doi: 10.1161/STROKEAHA.123.045015. Epub 2024 Jan 22.

  PMID: 38252759 RESULT

• Tomppo L, Martinez-Majander N, Qureshi MM, Nguyen TN, Nogueira RG, Nagel S, Demeestere J, Puetz V, Henon H, Olive-Gadea M, Marto JP, Dusart A, Ringleb PA, Zaidat OO, Haussen DC, Mohammaden MH, Abdalkader M, Raymond J, Ortega-Gutierrez S, Sheth SA, Yamagami H, Ramos JN, Caparros F, Kaiser DPO, Ribo M, Salazar Marioni S, Tanaka K, Virtanen P, Puri AS, Siegler JE, Zaidi SF, Jumaa M, Lin E, Mayol J, Ventura R, Winzer S, Klein P, Bellante F, Cespedes J, Wouters A, Masoud HE, Shu L, Castonguay AC, Herweh C, Cheng M, Hu W, Roy D, Yaghi S, Lemmens R, Cordonnier C, Mohlenbruch MA, Strbian D. Outcomes of Witnessed Versus Unwitnessed Patients With Stroke After Endovascular Therapy in the Extended Time Window. Stroke. 2025 Nov 12. doi: 10.1161/STROKEAHA.125.052355. Online ahead of print.

  PMID: 41221581 DERIVED

• Winzer S, Kaiser DPO, Qureshi MM, Castonguay AC, Strbian D, Nogueira RG, Nagel S, Raymond J, Abdalkader M, Demeestere J, Marto JP, Yamagami H, Tanaka K, Sheth SA, Dusart A, Michel P, Olive Gadea M, Ribo M, Zaidat OO, Haussen DC, Henon H, Mohammaden MH, Mohlenbruch MA, Siegler JE, Puri AS, Kaesmacher J, Klein P, Tomppo L, Caparros F, Ramos JN, Jumaa M, Zaidi S, Martinez-Majander N, Nannoni S, Vandewalle L, Bellante F, Galecio-Castillo M, Salazar-Marioni S, Virtanen P, Wouters A, Ventura R, Jesser J, Mujanovic A, Shu L, Qureshi A, Qiu Z, Masoud HE, Requena M, Sillanpaa M, Hu W, Lin E, Cordonnier C, Roy D, Yaghi S, Strambo D, Fischer U, Ortega-Gutierrez S, Lemmens R, Ringleb PA, Nguyen TN, Puetz V. Endovascular Therapy for Late-Window M2-Segment Middle Cerebral Artery Occlusion: Analysis of the CLEAR Study. Stroke. 2025 Jul;56(7):1671-1680. doi: 10.1161/STROKEAHA.124.048840. Epub 2025 May 22.

  PMID: 40405459 DERIVED

• Marto JP, Qureshi M, Nagel S, Nogueira RG, Henon H, Tomppo L, Ringleb PA, Haussen DC, Abdalkader M, Puetz V, Zaidat OO, Demeestere J, Ramos JN, Ribo M, Olive-Gadea M, Mohammaden MH, Ortega-Gutierrez S, Sheth S, Yamagami H, Dusart A, Raymond J, Caparros F, Kaiser D, Tanaka K, Virtanen P, Puri AS, Siegler JE, Zaidi SF, Jumaa MA, Lin E, Requena M, Michel P, Winzer SM, Klein P, Nannoni S, Bellante F, Salazar-Marioni S, Galecio-Castillo M, Wouters A, Ventura R, Mujanovic A, Shu L, Castonguay AC, Jesser J, Masoud HE, Kaesmacher J, Hu W, Roy D, Yaghi S, Asdaghi N, Strambo D, Lemmens R, Strbian D, Cordonnier C, Mohlenbruch M, Nguyen TN. Endovascular Therapy for Patients With Low NIHSS Scores and Large Vessel Occlusion in the 6- to 24-Hour Window: Analysis of the CLEAR Study. Neurology. 2025 Apr;104(7):e213442. doi: 10.1212/WNL.0000000000213442. Epub 2025 Mar 20.

  PMID: 40112237 DERIVED

• Siegler JE, Koneru M, Qureshi MM, Doheim M, Nogueira RG, Martinez-Majander N, Nagel S, Penckofer M, Demeestere J, Puetz V, Ribo M, Abdalkader M, Marto JP, Al-Bayati AR, Yamagami H, Haussen DC, Olive-Gadea M, Winzer S, Mohammaden MH, Lemmens R, Tanaka K, Virtanen P, Dusart A, Bellante F, Kaiser DPO, Caparros F, Henon H, Ramos JN, Ortega-Gutierrez S, Sheth SA, Nannoni S, Vandewalle L, Kaesmacher J, Salazar-Marioni S, Tomppo L, Ventura R, Zaidi SF, Jumaa M, Castonguay AC, Galecio-Castillo M, Puri AS, Mujanovic A, Klein P, Shu L, Farzin B, Moomey H, Masoud HE, Jesser J, Mohlenbruch MA, Ringleb PA, Strbian D, Zaidat OO, Yaghi S, Strambo D, Michel P, Roy D, Yoshimura S, Uchida K, Raymond J, Nguyen TN. CLEAR Thrombectomy Score: An Index to Estimate the Probability of Good Functional Outcome With or Without Endovascular Treatment in the Late Window for Anterior Circulation Occlusion. J Am Heart Assoc. 2024 Jul 16;13(14):e034948. doi: 10.1161/JAHA.124.034948. Epub 2024 Jul 9.

  PMID: 38979812 DERIVED

Related Links

• Endovascular Therapy in the Extended Time Window for Large Vessel Occlusion in Patients With Pre-Stroke Disability

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Thanh Nguyen, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: February 15, 2020
• Primary Completion: May 23, 2021
• Study Completion: May 1, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

FI (1); PT (1); BE (1); FR (1); US (7); ES (1); CA (1); DE (2); CH (2); JP (2)