Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR）

NCT07495969 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2025124
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, randomized, open-label, endpoint-blinded trial to compare the effects of endovascular recanalization plus aggressive medical management with aggressive medical management alone on stroke recurrence and mortality in patients with symptomatic non-acute intracranial artery occlusion.

Conditions

Ischemic Stroke; Symptomatic Non-acute Intracranial Artery Occlusion

Keywords

Endovascular Recanalization; Symptomatic Non-acute intracranial artery occlusion

Outcome Measures

Primary Outcomes (1)

• Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization

  Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization.

  Within 1 year after randomization

Secondary Outcomes (10)

• All cause mortality within 1 year after randomization

  Within 1 year after randomization

• Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization

  Within 1 year after randomization

• Disabling stroke within 1 year after randomization, defined as any of the following

  Within 1 year after randomization

• TIA in the same region as the qualifying artery within 1 year after randomization

  Within 1 year after randomization

• Unplanned revascularization (extracranial intracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization

  Within 1 year after randomization

Study Arms (2)

Intervention group

EXPERIMENTAL

Endovascular Recanalization Group

Procedure: Endovascular Recanalization Strategy

Control group

OTHER

Aggressive Medical Management Group

Drug: Aggressive Medical Management

Interventions

Endovascular Recanalization Strategy PROCEDURE

Balloon angioplasty and/or stenting;Combined with aggressive medical management.

Intervention group

Aggressive Medical Management DRUG

100 mg aspirin per day throughout the follow-up period and 75 mg clopidogrel per day (or ticagrelor or cilostazol) for the initial 90 days after randomization;Cerebrovascular risk factor management.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranging between 18 and 80 years.
• Ischemic events (TIA or ischemic stroke) related to the occluded artery, occurring despite aggressive medical management, with the last event occurring within between 14 and 90 days prior to enrollment.
• The modified Rankin Scale (mRS) score 0-2 at the time of enrollment.
• At least one risk factor for atherosclerosis.
• All enrolled patients refused bypass surgery.
• Signatured informed consent form.
• Occlusion of intracranial ICA, M1 segment of MCA, intracranial VA (with contralateral VA hypoplasia or occlusion), or BA, as confirmed by CT angiography (CTA) or digital subtraction angiography (DSA), and the length of the cclusion segment was≤15mm.
• A decrease of \>30% in cerebral blood flow in the territory distal to the target region, as assessed by CT perfusion (CTP); or inadequate collateral compensation indicated by digital subtraction angiography (DSA), defined as an ASITN/SIR collateral grade of 0-2; or evidence of hemodynamic ischemic lesions on CT or MRI.
• Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 for anterior circulation occlusion, or posterior circulation ASPECTS (pc-ASPECTS) ≥ 6 and pons-midbrain index (PMI) \< 3 for posterior circulation occlusion, as demonstrated by CT or MRI.
• Technical feasibility of endovascular recanalization (ER) in the qualifying artery evaluated by two experienced interventional neuroradiologists.

You may not qualify if:

• Severe stenosis (70%-99%) or occlusion of other arteries, or tandem stenosis (70%-99%) that is proximal to the qualifying artery.
• Intracranial hemorrhagic diseases such as definite Intracranial tumors, any intracranial vascular malformations, hemorrhagic transformation of infarction, spontaneous intracranial hemorrhage (cerebral parenchymal, subarachnoid, subdural, or epidural) within 30 days.
• Non atherosclerotic intracranial artery disease: arterial dissection, moyamoya disease or moyamoya syndrome demonstrated by imaging examination, or a definite medical history of autoimmune vasculitis.
• Evidence of cardioembolic embolism such as atrial fibrillation, prosthetic valve(s), infective endocarditis, mitral stenosis, atrial myxoma, intracardiac clot or vegetation, left ventricular aneurysms, etc.
• Known unstable angina or myocardial infarction within the last 6 months.
• Intolerance or allergic reaction to any treatment-related medication, including aspirin, clopidogrel, heparin, and local or general anesthetics.
• History of life-threatening allergy to contrast dye.
• Severe liver impairment (AST or ALT \> 3 times normal, cirrhosis), serum creatinine \> 3.0 mg/dl.
• Past history of EC-IC bypass surgery or EVT.
• Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment.
• Late-stage malignant tumors, cachexia, or other serious diseases and an expected life expectancy of less than 1 year.
• Pregnant, perinatal stage or lactating women.
• Any other condition (in the opinion of the site investigator) that inappropriate to participate this study.

Sponsors & Collaborators

• Feng Gao: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Feng Gao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Gao, MD

CONTACT

13581936066; gaofengletter@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-Director of Interventional Neuroradiology, Department of Neurology

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)