Early Neurological Clinical Recovery, 3 Months After Endovascular Treatment of an Acute Ischemic Stroke

Recruiting

• Conditions: Stroke, Acute

• Registration Number: NCT02879123
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

This trial aims at collecting standardized data concerning the early neurological clinical recovery of patients, 3 months after endovascular treatment of an acute ischemic stroke.

Although this outcome is a major issue of patients' prognosis, it is rarely collected at this stage of their follow-up.

Detailed Description

Stroke affects 1 patient every 4 minutes in France, with around 130,000 new patients each year. Early recanalisation is a major prognostic factor and the main therapeutic target in the acute phase of this disease. The recanalisation techniques currently developed are intravenous thrombolysis, intra-arterial thrombolysis and thrombectomy (or embolectomy). These therapies can be combined. Thrombectomy involves endovascular capture of the clot obstructing the intracranial artery.

Recent improvements in thrombectomy techniques have also contributed to the spread of this technique. Neurovascular units include endovascular treatment in their strategy for the early management of acute proximal occlusions of intracranial arteries in almost 1 in 3 cases. This approach is currently the subject of professional agreements. Mechanical thrombectomy has now been validated by studies showing a major reduction (-35%) in the disability associated with severe cerebral infarction and a reduction in mortality, with recanalisation rates ranging from 58 to 72%. This "recanalisation" criterion is of major importance because it largely determines the functional prognosis of patients following a cerebral infarction.

Patients are often followed up in the months following the operation by the neurology department that initially treated them, and in the first few weeks they may be admitted to follow-up care units. As a result, although the clinical outcome at 3 months is a major factor in patient prognosis, this information is rarely available. The aim of this study is to obtain standardised 3-month follow-up data for a large series of patients who have undergone endovascular treatment for stroke.

Study Timeline

• Study Start: 2015-11-12
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31
• Primary Completion: 2030-11-12
• Study Completion: 2031-05-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• acute ischemic stroke
• endovascular treatment

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
early neurological clinical recovery	3 months after endovascular treatment of an acute ischemic stroke	modified RANKIN score

Trial Locations

Locations (1)

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France