EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease, Phase IIb
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCedars-Sinai Medical Center
About this trial
ERSIAS IIb is a multicenter randomized controlled trial, with a Phase IIb design, to find out whether encephaloduroarteriosynangiosis (EDAS), a type of indirect surgical revascularization of the brain, added to intensive medical management, lowers the rate of recurrent stroke and death compared with intensive medical management alone. The trial enrolls 170 adults who have had a recent ischemic stroke or transient ischemic attack caused by intracranial atherosclerotic disease, with a narrowing or blockage of at least 70% of the intracranial internal carotid artery or the middle cerebral artery and reduced blood flow in the territory of that artery. Participants are assigned at random, in equal numbers, to EDAS plus intensive medical management or to intensive medical management alone, and are followed for 18 to 54 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Borderzone or superficial territorial ischemic stroke, or cortical TIA, within 30 days before enrollment, attributed to 70% to 100% atherosclerotic stenosis/occlusion of the intracranial ICA or the MCA (M1 or dominant/co-dominant M2). The eligible borderzone strokes are cortical (external) borderzone infarcts, located between the anterior and middle cerebral artery territories or between the middle and posterior cerebral artery territories; internal borderzone infarcts are not included. A cortical TIA is defined as transient cortical dysfunction evidenced by either visual field defects, spatial neglect, disorder of language, memory, or orientation. The corresponding cerebral artery atherosclerosis may be diagnosed by CTA, contrast-enhanced MRI, or catheter angiography.
Evidence of perfusion impairment (minimum: TMax delay ≥ 6 sec, vol ≥ 5 cc) in CTP or perfusion MRI.
Functional status better than severely disabled (mRS score 0-3).
Insulin-dependent diabetes for at least 15 years.
Disqualifiers
CT or MRI evidence of an isolated perforator stroke as qualifying event, defined by the Imaging Core based on established templates of cerebral vascular territories.
Angioplasty, stenting, or endarterectomy of an ipsilateral extracranial carotid artery within 90 days prior to enrollment or planned within 90 days following enrollment.
Stenting of the qualifying intracranial artery at any time, including a stent placed during an endovascular attempt for the qualifying event. Thrombectomy or angioplasty without stent placement is not an exclusion; eligibility is determined on imaging obtained after the procedure.
Intracranial tumor or intracranial vascular malformation.
Trial design
Design model
Parallel
Treatments tested in this trial
Encephaloduroarteriosynangiosis (EDAS)
Procedure/SurgeryEDAS is a form of indirect revascularization for cerebral arterial steno-occlusive disorders. The superficial temporal artery (STA) is dissected from the scalp, while maintaining its proximal and terminal connections to the external carotid artery and the skin tissues. The STA is then rerouted under the skull and placed in close proximity to the cortical branches of the middle cerebral artery without a direct anastomosis. EDAS is performed no later than 7 days after randomization.
Intensive medical management
Other interventionMedical management administered to both study arms following current and updated standard-of-care parameters, with guidance and oversight from the trial's Medical Management Core. Antiplatelet treatment with aspirin for the entire follow-up and dual antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor for up to 90 days after randomization; management of the primary risk factors targeting systolic blood pressure \<140 mmHg and LDL \<70 mg/dL; management of the secondary risk factors (diabetes, non-HDL cholesterol, smoking, weight, physical activity) with the assistance of a lifestyle modification program. The management protocol may be modified during the trial to reflect the most up-to-date, evidence-based practices; changes apply to participants in both groups.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: EDAS plus intensive medical managementExperimental treatment 2 interventions
Group B: Intensive medical management aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Any stroke or death within 30 days of randomization, or ischemic stroke in the territory of the qualifying artery thereafter
The composite of any stroke (ischemic or hemorrhagic) or death within 30 days of randomization plus recurrent ischemic stroke in the territory of the qualifying artery thereafter during full follow-up. Possible events are centrally adjudicated; the outcome measure is the centrally adjudicated, blinded event, not the site-determined event. Cumulative event rates in the two groups are compared by Kaplan-Meier estimates at 2.5 years.
Time frame
From randomization through the end of follow-up (minimum 18 months, maximum 54 months, mean 30 months)Secondary outcomes
1
Disabling or disability-worsening stroke, or fatal stroke
The composite of 1) any disabling/disability-worsening stroke (ischemic or hemorrhagic) or fatal stroke within 30 days after randomization and 2) any disabling/disability-worsening or fatal ischemic stroke in the territory of the qualifying artery through the end of follow-up. For patients non-disabled (modified Rankin Scale \[mRS\] 0-1) at trial entry: recurrent stroke yielding mRS 2 to 6. For patients already disabled (mRS 2-3) at trial entry: recurrent stroke yielding an mRS value 1 or more levels worse than baseline. Centrally adjudicated, blinded.
Time frame
From randomization through the end of follow-up (minimum 18 months, maximum 54 months, mean 30 months)2
Cognitive function measured by the Montreal Cognitive Assessment (MoCA)
Change from baseline in the MoCA score. Scores on the MoCA range from 0 to 30; higher values represent a better outcome.
Time frame
Baseline and 12, 24, 36 and 48 months after randomization3
Cognitive function measured by the National Institutes of Health Toolbox Cognition Battery (NIHTB-CB)
Change from baseline in cognitive function measured with the NIHTB-CB.
Time frame
Baseline and 12, 24, 36 and 48 months after randomization4
Mortality
Number of participants who die from any cause, by group.
Time frame
From randomization through the end of follow-up (minimum 18 months, maximum 54 months, mean 30 months)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov
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