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

Endovascular Recanalization Versus Aggressive Medical Management Alone for Symptomatic Non-Acute Intracranial Artery Occlusion: A Multicenter, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemic Stroke; Symptomatic Non-acute Intracranial Artery Occlusion
• Intervention / Treatment: Procedure: Endovascular Recanalization Strategy; Drug: Aggressive Medical Management

Detailed Description

This is a multicenter, randomized, open-label, endpoint-blinded trial comparing endovascular recanalization (ER) plus aggressive medical management (AMM) with aggressive medical management alone in patients with symptomatic non-acute intracranial artery occlusion. Randomization will be performed using a central interactive web response system (IWRS) with a 1:1 minimization method, stratified by age (<65 years vs ≥65 years), time from the last ischemic event to randomization (14-30 days vs 30-90 days), and occlusion site (anterior circulation vs posterior circulation). The primary endpoint is a composite of 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.

• Study Type: Interventional
• Enrollment (Estimated): 286
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Gao, MD; Phone Number: 13581936066; Email: gaofengletter@sina.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Clinical inclusion criteria:

1. Age ranging between 18 and 80 years.
2. 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.
3. The modified Rankin Scale (mRS) score 0-2 at the time of enrollment.
4. At least one risk factor for atherosclerosis.
5. All enrolled patients refused bypass surgery.
6. Signatured informed consent form.

Imaging inclusion criteria:

1. 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.
2. 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.
3. 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.
4. Technical feasibility of endovascular recanalization (ER) in the qualifying artery evaluated by two experienced interventional neuroradiologists.

Exclusion Criteria:

1. Severe stenosis (70%-99%) or occlusion of other arteries, or tandem stenosis (70%-99%) that is proximal to the qualifying artery.
2. 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.
3. Non atherosclerotic intracranial artery disease: arterial dissection, moyamoya disease or moyamoya syndrome demonstrated by imaging examination, or a definite medical history of autoimmune vasculitis.
4. 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.
5. Known unstable angina or myocardial infarction within the last 6 months.
6. Intolerance or allergic reaction to any treatment-related medication, including aspirin, clopidogrel, heparin, and local or general anesthetics.
7. History of life-threatening allergy to contrast dye.
8. Severe liver impairment (AST or ALT > 3 times normal, cirrhosis), serum creatinine > 3.0 mg/dl.
9. Past history of EC-IC bypass surgery or EVT.
10. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment.
11. Late-stage malignant tumors, cachexia, or other serious diseases and an expected life expectancy of less than 1 year.
12. Pregnant, perinatal stage or lactating women.
13. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Endovascular Recanalization Group	Procedure: Endovascular Recanalization Strategy; Balloon angioplasty and/or stenting;Combined with aggressive medical management.
Other: Control group; Aggressive Medical Management Group	Drug: Aggressive Medical Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality within 1 year after randomization	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	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	Disabling stroke within 1 year after randomization, defined as any of the following: ① modified Rankin Scale (mRS) score ≥3; ② an increase of ≥1 in the mRS score from baseline after stroke; ③ National Institutes of Health Stroke Scale (NIHSS) total score ≥7; ④ an increase of ≥4 in the NIHSS score from baseline after stroke.	Within 1 year after randomization
TIA in the same region as the qualifying artery 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	Unplanned revascularization (extracranialintracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization.	Within 1 year after randomization
Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction	Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction.	Within 1 year after randomization
A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization	A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization.	Within 1 year after randomization
mRS score at 1 year after randomization	mRS score at 1 year after randomization.	Within 1 year after randomization
Re occlusion rate at 1 year after randomization	Re occlusion rate at 1 year after randomization.	Within 1 year after randomization
Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications	Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications: in-stent thrombosis; distal embolism; symptomatic intracranial hemorrhage; parenchymal hematoma type 2 (as defined by the Heidelberg classification); arterial dissection; and vessel perforation.	At the end of the operation or intraoperative

Collaborators and Investigators

• Sponsor: Feng Gao
• Investigators: Principal Investigator: Feng Gao, MD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Endovascular Recanalization; Symptomatic Non-acute intracranial artery occlusion
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: HX-A-2025124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No