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Recruiting NCT02879123

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

Observational Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Stroke, Acute. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • early neurological clinical recovery [Time frame: 3 months after endovascular treatment of an acute ischemic stroke]

Eligibility criteria

Inclusion criteria

  • acute ischemic stroke
  • endovascular treatment

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Fondation Ophtalmologique Adolphe de Rothschild — Paris

Identifiers

NCT: NCT02879123 · RBC_2015_19

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗