New hope for stroke survivors: can a tiny tube in the brain prevent another attack?
NCT ID NCT07495969
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two approaches for people who have had a stroke or mini-stroke due to a blocked brain artery that hasn't opened on its own. One group gets a procedure to reopen the artery plus medication, while the other gets medication alone. The goal is to see which approach better prevents another stroke or death within a year. About 286 adults aged 18-80 will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 286 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke