Endovascular TreatmentNCT05988125
Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients
An observational study of Endovascular Treatment, run by Tingyu-Yi at 6 sites in China.
Trial summary
To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Treatment
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 1 Jan 2017to 31 Mar 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients receiving endovascular treatment.
Who may be able to join
- Acute ischemic stroke;
- 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);
- Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;
- Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent
Who cannot join
- Acute intracranial haemorrhage
- No evidence of large vessel occlusion on digital subtraction angiography.
- Patient bedridden or presenting from a nursing home
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154000
Lihua Xu, MD, 13846178333, drxulihua@163.com
- Recruiting
Gansu provincial hospital of TCM
Lanzhou, Gansu, 730050
Hua Cao, 18919810265, shaoya20042001@126.com
- Recruiting
Department of Neurology, The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
xiao-bing Li, M.D., 13970935284, lxb0203208@126.com
- Recruiting
Shenyang First People's Hospital
Shenyang, Liaoning, 110091
Yi Sui, MD, 13998352587, tjyiia@hotmail.com
- Recruiting
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, 138000
Dong-sheng Ju, MD, 13894158599, judongsheng_1981@163.com
- Recruiting
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, 36300
Wenhuo Chen, MD, 13806906089, 13806906089@126.com
About this study
Official title: Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China
To investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients with endovascular therapy.
Read the 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.
- Conditions
- Endovascular Treatment
- Keywords
- acute Ischemic Stroke, Endovascular Treatment
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
The modified Rankin Scale score at 90 days
The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome.
0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.
Measured: 90 days
Secondary outcomes (2)
Successful reperfusion rate
Measured: 90 days
symptomatic intracranial hemorrhage or death within 90 days after stroke onset.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Tingyu-Yi
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, The First Affiliated Hospital of Nanchang University, First People's Hospital of Shenyang
- Responsible party
- Sponsor-investigator, Tingyu-Yi, Zhangzhou Municipal Hospital
- Investigators
- Wen-huo Chen, bachelor, Principal investigator, Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988125
- Sponsor's protocol ID
- ETERNITY
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry Study of Endovascular Treatment for Acute Ischemic Stroke Patients in China
- ClinicalTrials.gov ID
- NCT05988125
- Acronym / sponsor ID
- ETERNITY
- Conditions
- Endovascular Treatment
- Keywords
- acute Ischemic Stroke, Endovascular Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tingyu-YiUniversity, hospital or other
- Collaborators
- Fujian Medical University Union Hospital, The First Affiliated Hospital of Nanchang University, First People's Hospital of Shenyang
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients receiving endovascular treatment.
Key inclusion criteria (4 listed)
- Acute ischemic stroke;
- 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);
- Initiation of any type of endovascular treatment, including mechanical thrombectomy, aspiration, angioplasty, and stenting;
- Informed Consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent
Key exclusion criteria (4 listed)
- Acute intracranial haemorrhage
- No evidence of large vessel occlusion on digital subtraction angiography.
- Patient bedridden or presenting from a nursing home
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The modified Rankin Scale score at 90 days
Time frame: 90 days
The range of the modified Rankin Scale is from 0 to 6. A higher score indicates a worse outcome. 0-No symptoms; 1-No significant disability; 2-Slight disability; 3-Moderate disability; 4-Moderately severe disability; 5-Severe disability; 6-Dead.
2 secondary outcomes
Successful reperfusion rate
Time frame: 90 days
symptomatic intracranial hemorrhage or death within 90 days after stroke onset.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-huo Chen, bachelor principal investigator
Zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Treatment, run by Tingyu-Yi at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen-huo Chen, bachelor (+86-05962082582, doctorwwenhuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The modified Rankin Scale score at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.