EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease

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.

Inclusion Criteria: 1. 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. 2. Evidence of perfusion impairment (minimum: TMax delay ≥ 6 sec, vol ≥ 5 cc) in CTP or perfusion MRI. 3. Functional status better than severely disabled (mRS score 0-3). 4. Age ≥18 years and ≤90 years. If the patient is 18 to 49 years of age, at least 1 of the following should be present: * Insulin-dependent diabetes for at least 15 years. * At least 2 of the following atherosclerotic risk factors: SBP ≥130 mmHg or on antihypertensive therapy; dyslipidemia (LDL \>130 mg/dL, HDL \150 mg/dL, or on lipid-lowering therapy); smoking; non-insulin-dependent diabetes or insulin-dependent diabetes less than 15 years in duration; family history of any of the following: myocardial infarction, coronary artery bypass, coronary artery angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was \3× normal, cirrhosis) that may prevent the use of statins. 23. Severe renal impairment (creatinine \>3.0 mg/dL or on dialysis). 24. Other major surgery planned in the next 90 days after enrollment that may require suspension of antiplatelet therapy. 25. Dementia or a psychiatric problem that prevents the patient from reliably following an outpatient program. 26. Co-morbid conditions that may limit survival to less than 3 years. 27. Pregnancy or of childbearing potential and unwilling to use contraception for the duration of the dual antiplatelet treatment period of the trial. 28. Active enrollment in another therapeutic trial that would conflict with this trial. 29. Evidence of active untreated systemic or serious infections (i.e., pneumonia, complicated urinary infection). 30. Body mass index (BMI) ≥40 kg/m2.