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Multicenter Clinical Trial of Revascularization Treatment for Acute Ischemic Stroke

Multicenter Clinical Trial of Revascularization Treatment for Acute Ischemic Stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000033456
Enrollment
Unknown
Registered
2020-06-01
Start date
2017-06-01
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

acute ischemic stroke

Interventions

Case series:Case series

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. Having been ruled out intracranial hemorrhage by brain CT; 3. Ischemic stroke patients who intend to undergo intravenous thrombolysis, arterial thrombolysis or mechanical thrombectomy meet the following criteria: Patients with intravenous thrombolysis: (1) Within 4.5 hours after the onset, a pre-stroke score of 0-1 on the mRS, and a score of >=4 on the NIHSS at the time of onset; (2) Within 4.5-9 hours after the onset, a pre-stroke score of 0-1 on the mRS, and a score of >=4 on the NIHSS at the time of onset, CT perfusion or magnetic resonance perfusion / DWI showed a ratio of low perfusion volume to infarct core volume of >1.2 and absolute difference of >10 ml, and the infarct core of 30% compared with the contralateral side, and the infarct core is defined as Tmax> 6s); (3) Wake-up stroke or ischemic stroke with unknown onset time: magnetic resonance DWI / Flair examination is performed, which is in accordance with the DWI / Flair mismatch model (DWI shows ischemic focus, and no abnormal signal is seen on FLAIR); Patients with arterial thrombolysis and mechanical thrombectomy: (1) Within 6 hours of onset, a pre-stroke score of 0-1 on mRS, a score of >=6 on NIHSS, and a score of >=6 on ASPECT at the time of onset, CTA or MRA implies stroke is caused by internal carotid artery or middle cerebral artery M1 segment occlusion; (2) Within 6 hours of onset, a pre-stroke score of 0-1 on mRS, a score of =10 on NIHSS and a score of >=6 on ASPECT at the time of onset, CTA or MRA confirms extracranial or intracranial segment of internal carotid artery or M1 / M2 segment of middle cerebral artery occlusion, CTP or magnetic resonance perfusion / DWI show small infarct core and large ischemic penumbra (a ratio of low perfusion volume to infarct core volume of > 1.8, and absolute difference of =15 ml, and infarct core of <70 ml); (5) Within 24 hours of onset, CTA or MRA confirms the acute stroke is caused by occlusion of vertebral artery and basilar artery, and the benefit of arterial thrombolysis or mechanical thrombectomy assessed by doctors is greater than the risk. Patients of intravenous thrombolysis bridging treatment with mechanical thrombectomy: If the symptoms do not improve significantly after intravenous thrombolysis, patients who meet the above mechanical thrombectomy indications should undergo bridging treatment; 4. Patients and their families should sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Neuroimaging examination (CT / MRI) suggests intracranial hemorrhagic diseases (eg, hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.); 2. Transient ischemic attack; 3. Complicated with malignant tumors, blood, digestive or other systemic diseases or diseases with bleeding tendency; 4. Patients with other mental illnesses who are unable or unwilling to cooperate, dementia patients; 5. According to the "Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018", patients who belong to the contraindication of intravenous thrombolysis; 6. According to the "Guidelines for early intravascular interventional diagnosis and treatment of acute ischemic stroke in China 2018", patients who belong to the contraindication of intravascular interventional therapy; 7. The investigator considers it inappropriate to participate in other types of this study.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with score of 0-1 on mRS;

Secondary

MeasureTime frame
Vascular reperfusion;Proportion of patients with recanalization and reclosure;Proportion of patients with a NIHSS score reduction of >=4 points;Proportion of patients with symptomatic intracranial hemorrhage;Infarct volume, edema volume;Proportion of patients with a NIHSS score reduction of =4 points;Proportion of patients with a change in NIHSS score of =8 or NIHSS score of =1;mRS score distribution;Number of patients with all-cause mortality;Proportion of patients with a change in NIHSS score of =8 or NIHSS score of =1;mRS score distribution;Number of patients with all-cause mortality;

Countries

China

Contacts

Public ContactBo Hu

Department of Neurology, Union Hospital

hubo@mail.hust.edu.cn+86 13707114863

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026