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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Society of Vascular and Interventional Neurology | UNKNOWN |
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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.
Additional subgroup analysis that are planned include:
Futile Reperfusion in the Extended Window.
We will evaluate clinical, imaging and time metric factors associated with successful reperfusion yet poor outcomes (modified Rankin 3-6) in the 6-24 hour window.
An evaluation of factors associated with symptomatic intracranial hemorrhage and mortality will be conducted.
Pre-Stroke disability.
Intravenous Thrombolysis in the Extended Window
We aim to compare the safety and outcomes of bridging IVT in patients with acute ischemic stroke due to large vessel occlusion (LVO) who underwent EVT 6 to 24 hours after time-last-known-well.
Medical Management vs CT selected Patients
We hypothesize that in patients with large vessel occlusion in the anterior circulation presenting in the 6 to 24 hour window, patients who are selected by non-contrast CT and treated with endovascular therapy have more favorable outcomes (ordinal mRS shift) as compared to patients who are medically managed.
Sex differences in the Extended Window
In this study we aim to asses whether there are sex differences in clinical outcomes and safety of EVT in patients presenting in the 6-24 hour time window.
Transfer Analysis
It is not well established whether transfer patients presenting in the extended window should have repeat imaging upon receipt at the endovascular center after an interim time window.
We hypothesize that within a 0 to 2, or 2 to 4 hour delay between images of the primary stroke center to receiving endovascular center, transferred patients in the extended window, who undergo thrombectomy with successful reperfusion will have similar outcomes in patients with or without repeat imaging at the receiving center.
We aim to compare the safety and outcomes of late-window bridging IVT vs. direct EVT for LVO acute ischemic stroke in the 6-24 hour time window.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial hemorrhage incidence | Number of cases of intracranial hemorrhage divided by appropriate denominator. | 90 days |
| Mortality rate | Number of deaths divided by appropriate denominator. |
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Inclusion Criteria:
Exclusion Criteria:
-Time last seen well to treatment <6 hours from last known well
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Thanh Nguyen, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health; Marcus Stroke & Neuroscience Center | Atlanta | Georgia | 30303 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34747975 | Result | 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. | |
| 36252092 |
| Label | URL |
|---|---|
| Endovascular Therapy in the Extended Time Window for Large Vessel Occlusion in Patients With Pre-Stroke Disability | View source |
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| 90 days |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| University of Massachusetts | Worcester | Massachusetts | 01655 | United States |
| Cooper University Health Care | Camden | New Jersey | 08103 | United States |
| Upstate University Hospital | Syracuse | New York | 13202 | United States |
| University of Toledo | Toledo | Ohio | 43606 | United States |
| Mercy Health Neuroscience Institute | Toledo | Ohio | 43608 | United States |
| UZ Leuven | Leuven | Belgium |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 0C1 | Canada |
| Helsinki University Hospital | Helsinki | Finland |
| Universite de Lille | Lille | France |
| University Hospital Carl Gustav Carus | Dresden | Germany |
| Heidelberg University | Heidelberg | Germany |
| National Cerebral and Cardiovascular Center | Osaka | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | Japan |
| Hospital de Egas Moniz | Lisbon | Portugal |
| Val D'Hebron | Barcelona | Spain |
| Bern University Hospital | Bern | Switzerland |
| Lausanne University Hospital | Lausanne | Switzerland |
| 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. |
| 36332983 | 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. |
| 38748598 | 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. |
| 38757713 | 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. |
| 38709999 | 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. |
| 38252759 | 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. |
| 41221581 | Derived | 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. 2026 Feb;57(2):362-370. doi: 10.1161/STROKEAHA.125.052355. Epub 2025 Nov 12. |
| 40405459 | 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. |
| 40112237 | 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. |
| 38979812 | 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. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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