New stroke study: does adding a stent after clot removal help?
NCT ID NCT07618052
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether doing a balloon angioplasty or placing a stent right after removing a blood clot from the brain can help people who have a stroke caused by a hardened artery. About 420 adults will be in the study. The goal is to see if this extra step improves recovery, lowers the chance of another stroke, and reduces the risk of death compared to standard care alone.
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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 420 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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 years and older
- 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.
Inclusion Criteria: 1. Age≥18 years. 2. Time interval from symptom onset to puncture ≤24 hours. 3. National Institute of Health Stroke Scale (NIHSS) Score ≥6 before randomisation. 4. Pre-stroke modified Rankin Scale (mRS) of 0-2. 5. Each patient or their legal representative must provide written informed consent before enrolment. Imaging Inclusion Criteria: 1. For patients with anterior circulation stroke, a CT or DWI-based Alberta Stroke Program Early CT Score (ASPECTS) of ≥6 is required. 2. For patients with posterior circulation stroke, CT or DWI-based posterior circulation ASPECTS (pc-ASPECTS) of ≥6 and Pons-Midbrain Index (PMI) of \<3 are required. Angiographic Inclusion Criteria: 1. Acute ischemic stroke (AIS) resulting from large vessel occlusion (LVO) involving the intracranial internal carotid artery, the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, or the basilar artery, with high suspicion of intracranial atherosclerotic stenosis-related large-vessel occlusion (ICAS-LVO). 2. Part 1 (RCT): Successful recanalization of the occluded artery (eTICI ≥ 2b) with residual stenosis ≥ 70% after 1-2 thrombectomy attempts. Part 2 (Prospective observational cohort): Failure to achieve successful recanalization (eTICI 0-2a) after at least two thrombectomy attempts. All other inclusion criteria are identical to those for Part 1. 3. Occluded artery amenable to angioplasty (balloon dilation and/or stenting) by the judgement of the treating neurointerventionalist. Exclusion Criteria: 1. Any sign of intracranial hemorrhage (ICH, except microbleeds) on baseline brain imaging. 2. CT or MR imaging evidence of intracranial tumor (except small meningiomas or cerebral aneurysms \< 3mm in diameter). 3. Any indication of intracranial vessel perforation during thrombectomy.. 4. Presence of tandem lesion in the extracranial segment of the internal carotid artery or vertebral artery, or intracranial arterial stenosis with distal vessel occlusion.. 5. Stenosis caused by non-atherosclerotic intracranial arteriopathies (e.g., autoimmune vasculitis, vasospasm, cerebral artery dissection). 6. Evidence of cardioembolism (e.g., atrial fibrillation, prosthetic heart valve, infective endocarditis, mitral stenosis, atrial myxoma, intracardiac thrombus/vegetation, left ventricular aneurysm, etc.). 7. Contraindication for antiplatelet treatment. 8. Excessive vascular tortuosity or anatomical variants that may preclude successful delivery or positioning of interventional devices. 9. History of contraindication to the use of contrast medium. 10. Refractory hypertension (defined as systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg) that cannot be controlled by drug treatment. 11. Known hereditary or acquired bleeding tendency, lack of coagulation factors, or oral anticoagulants with INR\>1.5. 12. Blood glucose\<2.8 or\>22.2 mmol/L; Platelet count\<100\*109/L, serum creatinine\>2.0 g/L (177 μ mol/L), or glomerular filtration rate\<30 ml/(min\*1.73 m2). 13. Concurrent participation in another drug or device trial, or expected participation within the following 3 months. 14. Patients whose life expectancy is less than 1 year (such as patients with malignant tumor, advanced cardiopulmonary disease, etc.). 15. Known pregnancy or lactation, or positive pregnancy test before randomization (or before enrollment). 16. Known dementia or psychiatric disorder that precludes completion of neurological assessments and follow-up. 17. Any other condition deemed by the site investigator to make the patient unsuitable for participation.
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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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- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Cancer patients face a hidden Second-Stroke threat, and 24 hospitals are mapping it
- Can tiny neural exosomes help the brain heal after a severe stroke?