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Preventing Recurrent Stroke in Non-Acute Intracranial Artery Occlusion by Endovascular Recanalization Therapy: a Multicenter, Randomized, Open-Label, Blinded End-Point Trial

Preventing Recurrent Stroke in Non-Acute Intracranial Artery Occlusion by Endovascular Recanalization Therapy: a Multicenter, Randomized, Open-Label, Blinded End-Point Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042756
Enrollment
Unknown
Registered
2021-01-27
Start date
2022-01-01
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral vascular disease

Interventions

endovascular recanalization with intensive drug treatment group:endovascular recanalization with intensive drug treatment
intensive drug treatment group:intensive drug treatment

Sponsors

The First Affiliated Hospital of Army Medical University, PLA; Beijing Tiantan Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) The age was 18-80 years old; 2) DSA confirmed occlusion of intracranial segment of internal carotid artery and M1 segment of middle cerebral artery (mTICI grade 0); 3) The time from onset of ischemic stroke to randomized treatment was more than 7 days and less than 3 months (confirmed by imaging or inferred from responsible events); 4) The responsible events were related to target vessel occlusion (including ischemic stroke and TIA); 5) TOAST classification was atherosclerosis; 6) CTP or PWI assessment indicate the presence of hypoperfusion in the target vessel area; 7) Patients or legal representatives sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Previous or current intracranial hemorrhage (confirmed by imaging or written materials, microbleeds on SWI are not included); 2) Previous history of massive cerebral infarction (infarction volume > 70ml or infarct area greater than 1 / 3 of middle cerebral artery blood supply area); 3) Severe life dysfunction before onset (MRS score > 3); 4) Patients with severe allergy to iodine contrast agent or anti platelet drugs (aspirin, clopidogrel) or statins; 5) Stent implantation was performed in ipsilateral internal carotid artery or middle cerebral artery; 6) Tandem extracranial-intracranial lesions of the target vessels; 7) The tortuous approach or other difficulties lead to the failure of surgical instruments to reach the target vessels; 8) Active bleeding or known bleeding tendency (e.g. receiving anticoagulant therapy or severe coagulation dysfunction); 9) Platelet count was lower than 100 x 10^9/L; 10) Severe heart, liver and kidney dysfunction or other terminal illness; 11) There were gastrointestinal or urinary bleeding, acute myocardial infarction, craniocerebral trauma or major surgical operation in the past month; 12) Patients with severe coronary artery stenosis or occlusion , untreated intracranial aneurysms, intracranial tumors (except meningiomas) or intracranial vascular malformations; 13) Blood pressure was higher than 185 / 110mmhg, blood glucose 18mmol / L; 14) Pregnancy or lactation; 15) Patients with dementia or mental illness are known to be unable to complete neurological assessment; 16) The life expectancy is less than 1 year; 17) Enrollment in another study that would conflict with the current study; 18) Neurologists consider other special circumstances unsuitable for this study

Design outcomes

Primary

MeasureTime frame
Recurrence rate of ipsilateral ischemic stroke or TIA within 1 year after enrollment;

Secondary

MeasureTime frame
Compared with the baseline level, the improvement of cognitive function at 90 days after enrollment (MoCA score and MMSE score);Compared with the baseline level, the improvement of cognitive function (MoCA score and MMSE score) at 1 year after enrollment;Incidence of total ischemic stroke or TIA within 1 year after enrollment;Neurological function evaluation (MRS score) 90 days after enrollment;Neurological function evaluation (MRS score) at 1 year after enrollment;

Countries

China

Contacts

Public ContactZhongrong Miao, Zhenhua Zhou, Kangning Chen

Beijing Tiantan Hospital affiliated to Capital Medical University

exploiter001@126.com+86 13601243293, +86 13594145356, +86 13983880255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026