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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823481
Other study ID # CE_20210126_8_PSS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date December 31, 2021

Study information

Verified date December 2022
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria: - Age = 18 and < 96 - Clinical signs consistent with acute ischemic stroke - Patients who presented within 6 hours of stroke symptoms onset - Isolated occlusion of the anterior or the posterior artery Exclusion Criteria: - Administration of recanalization treatment before hospital admission

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Fondation Adolphe de Rothschild Paris Ile-de-France

Sponsors (1)

Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinico-radiological evolution of IS patients with isolated occlusion of the anterior or posterior cerebral artery. Good Neurological Condition Good neurological outcome (GNO) at 3 months will defined using the modified Rankin Scale (mRS). A normal/near normal outcome after procedure is associated with a mRS Scale score = 0-1 and severe disability/death is associated with a mRS Scale score = 5-6 90 days
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