CT (Computerized Tomography) for Late EndovasculAr Reperfusion

NCT ID: NCT04096248

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2790 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-15
• Study Completion Date: 2022-05-01

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.

Detailed Description

Additional subgroup analysis that are planned include:

1. 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.

2. Pre-Stroke disability.

1. EVT patients treated in the extended window compared to Medical Management

2. EVT patients treated in the extended window with pre-existing disability vs. those without pre-existing disability

3. 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.

4. 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.

5. 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.

6. 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.

Conditions

Stroke, Cardiovascular

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

-Time last seen well to treatment <6 hours from last known well

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Society of Vascular and Interventional Neurology

UNKNOWN

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thanh Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Grady Health; Marcus Stroke & Neuroscience Center

Atlanta, Georgia, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Massachusetts

Worcester, Massachusetts, United States

Cooper University Health Care

Camden, New Jersey, United States

Upstate University Hospital

Syracuse, New York, United States

University of Toledo

Toledo, Ohio, United States

Mercy Health Neuroscience Institute

Toledo, Ohio, United States

UZ Leuven

Leuven, , Belgium

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, 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

Countries

United States; Belgium; Canada; Finland; France; Germany; Japan; Portugal; Spain; Switzerland

References

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.

Reference Type: RESULT

PMID: 34747975 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36252092 (View on PubMed)

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.

Reference Type: RESULT

PMID: 36332983 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38748598 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38757713 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38709999 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38252759 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40405459 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 40112237 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38979812 (View on PubMed)

Related Links

https://j-stroke.org/journal/view.php?number=531

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

Other Identifiers

H-37843

Identifier Type: -

Identifier Source: org_study_id