Symptomatic Non-acute Intracranial Artery OcclusionNCT07495969
Randomized Clinical Trial of Endovascular Recanalization for Symptomatic Non-Acute Intracranial Artery Occlusion（REPAIR）
A study testing Endovascular Recanalization Strategy and Aggressive Medical Management in people with Symptomatic Non-acute Intracranial Artery Occlusion and Ischemic Stroke, run by Feng Gao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Non-acute Intracranial Artery Occlusion, Ischemic Stroke
- What is being tested?
- Endovascular Recanalization Strategy and Aggressive Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: 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.
Read the 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.
- Being tested
- Endovascular Recanalization Strategy, Aggressive Medical Management
- Keywords
- Endovascular Recanalization, Symptomatic Non-acute intracranial artery occlusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular Recanalization StrategyProcedure or surgery
Balloon angioplasty and/or stenting;Combined with aggressive medical management.
Aggressive Medical ManagementDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Endovascular Recanalization Group Receives: Procedure: Endovascular Recanalization Strategy |
| Control group | Other | Aggressive Medical Management Group Receives: Drug: Aggressive Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 year after randomization
Secondary outcomes (10)
All cause mortality within 1 year after randomization
All cause mortality within 1 year after randomization.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 1 year after randomization
mRS score at 1 year after randomization
mRS score at 1 year after randomization.
Measured: Within 1 year after randomization
Re occlusion rate at 1 year after randomization
Re occlusion rate at 1 year after randomization.
Measured: 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.
Measured: At the end of the operation or intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Non-acute Intracranial Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Feng Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Gao, Beijing Tiantan Hospital
- Investigators
- Feng Gao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495969
- Sponsor's protocol ID
- HX-A-2025124
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07495969
- Acronym / sponsor ID
- HX-A-2025124
- Keywords
- Endovascular Recanalization, Symptomatic Non-acute intracranial artery occlusion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Feng GaoUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Endovascular Recanalization StrategyEndovascular Recanalization Group |
| Control group | Other | Drug: Aggressive Medical ManagementAggressive Medical Management Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular Recanalization StrategyBalloon angioplasty and/or stenting;Combined with aggressive medical management. | Procedure or surgery | Intervention group |
| Aggressive Medical Management100 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. | Drug | Control group |
Primary outcome
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
Time frame: Within 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.
10 secondary outcomes
All cause mortality within 1 year after randomization
Time frame: Within 1 year after randomization
Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization
Time frame: Within 1 year after randomization
Disabling stroke within 1 year after randomization, defined as any of the following
Time frame: Within 1 year after randomization
TIA in the same region as the qualifying artery within 1 year after randomization
Time frame: Within 1 year after randomization
Unplanned revascularization (extracranial intracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization
Time frame: Within 1 year after randomization
Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction
Time frame: Within 1 year after randomization
A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization
Time frame: Within 1 year after randomization
mRS score at 1 year after randomization
Time frame: Within 1 year after randomization
Re occlusion rate at 1 year after randomization
Time frame: Within 1 year after randomization
Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications
Time frame: At the end of the operation or intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Gao, MD principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular Recanalization Strategy and Aggressive Medical Management in people with Symptomatic Non-acute Intracranial Artery Occlusion and Ischemic Stroke, run by Feng Gao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Gao, MD (13581936066, gaofengletter@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Within 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.