Endovascular Acute Stroke Intervention Trial - the EASI Trial
Status:
Suspended
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
Stroke constitutes the primary cause of acquired disability in adults and the second cause of
dementia following Alzheimer disease. It has been shown that patients with a moderate to
severe clinical score have occlusion of brain large vessels, resulting in a worse clinical
outcome. Many studies have demonstrated that early recanalization after IV rtPA is more
restricted, the larger and more proximal the artery. Several systems for mechanical
intracranial arterial thrombectomy of large trunks have recently been proposed and are now
available. Potential advantages of these mechanical systems on chemical thrombolysis are
speed (a few minutes versus 1 hour) and absence of thrombolytic injection.
The objective of the EASI trial is thus to:
- To validate intra-arterial thrombectomy use during the acute phase of cerebral stroke in
patients treated with IV thrombolysis or in patients for whom thrombolysis is
contra-indicated.
- To determine whether a combined approach, standard treatment plus thrombectomy, is
superior to standard treatment alone within 5 h of the appearance of symptoms, in
patients with occlusion of proximal cerebral arteries following moderate to severe
stroke (NIHSS larger than or equal to 8), evaluated at 3 months.
The design is a randomized, controlled multicentric trial, with a parallel comparison between
standard and combined (standard plus thrombectomy) treatment.
480 patients fulfilling eligibility criteria will be sufficient to demonstrate the primary
hypothesis of a 15% difference in number of subjects with a favorable mRS (less than or equal
to 2) at 3 months, with the assumption of a 25% efficacy for IV thrombolytic treatment at 3
months.
IV thrombolysis is carried out according to standard practice. Mechanical thrombectomy is
carried out with already approved devices, according to the manufacturer's instructions,
following a diagnostic cerebral angiography.
The primary efficacy endpoint is clinical: favorable mRS (less than or equal to 2) at 3
months.
The primary safety endpoint is rate of death at 3 months and rate of symptomatic hemorrhage
at 24 hours.
If the primary hypothesis is validated, expected benefits of this study is a higher rate of
autonomy for stroke patients with all the attendant consequences: reduction in hospital
stays, and a faster return to the activities of daily life.