Clinical trial NCT05988125: Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients
Official title: Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endovascular Treatment
Keywords: acute Ischemic Stroke
Endovascular Treatment
Lead sponsor: Zhangzhou Municipal Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Medical University Union Hospital
name: The First Affiliated Hospital of Nanchang University
name: First People's Hospital of Shenyang
First posted: 2023-08-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients receiving endovascular treatment.

Brief summary: To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Detailed description: Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients is an academic,independent, pragmatic , prospective, multicenter, observational registry study. The acute ischemic stroke patients undergone endovascular therapy will be enrolled in stroke centers. Baseline information and clinical follow-up information at 90 days of stroke onset are collected. Data collected include demographics, comorbidities, pathogenesis, blood pressures, stroke severity on admission, time intervals, reperfusion condition, and functional outcome, et al. The study aims to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.

Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke;
2. Brain imaging confirmed intracranial large vessel occlusion: intracranial internal carotid artery (ICA), middle cerebral artery (MCA M1/M2), anterior cerebral artery (ACA A1/A2), basilar artery (BA), vertebral artery (VA V4), and posterior cerebral artery (PCA P1);
3. Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;
4. Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent

Exclusion Criteria:

1. Acute intracranial haemorrhage
2. No evidence of large vessel occlusion on digital subtraction angiography.
3. Patient bedridden or presenting from a nursing home
4. Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -

Primary outcomes:
measure: The modified Rankin Scale score at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Successful reperfusion rate
timeFrame: 90 days
measure: symptomatic intracranial hemorrhage or death within 90 days after stroke onset.
timeFrame: 90 days
Other outcomes:
Locations:
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu provincial hospital of TCM
state: Gansu
city: Jiamusi
country: China
facility: Jiamusi Central Hospital
state: Heilongjiang
city: Nanchang
country: China
facility: Department of Neurology, The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: SongYuan
country: China
facility: Songyuan Jilin Oilfield Hospital
state: Jilin
city: Shenyang
country: China
facility: Shenyang First People's Hospital
state: Liaoning
Study officials:
affiliation: Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
name: Wen-huo Chen, bachelor
role: PRINCIPAL_INVESTIGATOR
References: