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NOT YET RECRUITING
NCT07864649
NA

EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-occlusive Disease

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: ERSIAS IIb. EDAS Revascularization for Symptomatic Intracranial Atherosclerotic Steno-Occlusive Disease. Phase IIb Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2027-05-01

Completion Date

2031-11-30

Last Updated

2026-10-13

Healthy Volunteers

No

Interventions

PROCEDURE

Encephaloduroarteriosynangiosis (EDAS)

EDAS 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.

OTHER

Intensive medical management

Medical 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.