CT (Computerized Tomography) for Late EndovasculAr Reperfusion

Stroke, Cardiovascular Clinical Trial

— CLEAR  

Official title:

Non-Contrast CT vs CTP or MRI Selection vs Medical Management in Late Presentation of Large Vessel Occlusion Stroke, 6-24 Hours. A Multicenter Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096248
• Other study ID #: H-37843
• Status: Completed
• Start date: February 15, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2024
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2790
• Est. completion date: May 1, 2022
• Est. primary completion date: May 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Infarction
• Stroke
• Stroke, Cardiovascular

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Finland	Helsinki University Hospital	Helsinki
France	Universite de Lille	Lille
Germany	University Hospital Carl Gustav Carus	Dresden
Germany	Heidelberg University	Heidelberg
Japan	National Cerebral and Cardiovascular Center	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Portugal	Hospital de Egas Moniz	Lisbon
Spain	Val D'Hebron	Barcelona
Switzerland	Bern University Hospital	Bern
Switzerland	Lausanne University Hospital	Lausanne
United States	Grady Health; Marcus Stroke & Neuroscience Center	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Cooper University Health Care	Camden	New Jersey
United States	Upstate University Hospital	Syracuse	New York
United States	Mercy Health Neuroscience Institute	Toledo	Ohio
United States	University of Toledo	Toledo	Ohio
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	Medtronic, Society of Vascular and Interventional Neurology

Countries where clinical trial is conducted

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

References & Publications (7)

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, D — View Citation

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 — View Citation

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 — View Citation

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, S — View Citation

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, Winz — View Citation

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 — View Citation

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, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intracranial hemorrhage incidence	Number of cases of intracranial hemorrhage divided by appropriate denominator.	90 days
Secondary	Mortality rate	Number of deaths divided by appropriate denominator.	90 days

External Links

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