Acute Ischemic StrokeNCT05213754
Acute Ischemic Stroke Registry for Endovascular Treatment
An observational study of Acute Ischemic Stroke, run by Capital Medical University at 1 site in China.
Trial summary
The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment will be enrolled in stroke centers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Endovascular Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute ischemic stroke patients with large vessel occlusion receiving endovascular treatment.
Who may be able to join
- Diagnosis of acute ischemic stroke;
- 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 intra-arterial thrombolysis, mechanical thrombectomy, aspiration, angioplasty, and stenting;
- Verbal and written informed consent was provided at the time of admission by patients or their legal authorized representatives.
Who cannot join
- No evidence of large vessel occlusion on digital subtraction angiography.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Xunming Ji, MD, 010-83198952, jixm@ccmu.edu.cn
About this study
Official title: Acute Ischemic Stroke Registry for Endovascular Treatment in China
The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Endovascular Treatment
- Keywords
- Acute ischemic stroke, Endovascular treatment, Outcome, Registry
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TreatmentProcedure or surgery
Re-open the occluded cerebral artery using endovascular treatment
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213754
- Sponsor's protocol ID
- AIS-EVT
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Ischemic Stroke Registry for Endovascular Treatment in China
- ClinicalTrials.gov ID
- NCT05213754
- Acronym / sponsor ID
- AIS-EVT
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Endovascular treatment, Outcome, Registry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Jan 2022 (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.
The Acute Ischemic Stroke Registry for Endovascular Treatment (AIS-EVT) is an academic, prospective, multicenter, observational registry study. Consecutive stroke patients treated with endovascular treatment 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute ischemic stroke patients with large vessel occlusion receiving endovascular treatment.
Key inclusion criteria (4 listed)
- Diagnosis of acute ischemic stroke;
- 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 intra-arterial thrombolysis, mechanical thrombectomy, aspiration, angioplasty, and stenting;
- Verbal and written informed consent was provided at the time of admission by patients or their legal authorized representatives.
Key exclusion criteria (1 listed)
- No evidence of large vessel occlusion on digital subtraction angiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular TreatmentRe-open the occluded cerebral artery using endovascular treatment | Procedure or surgery | – |
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Capital Medical University at 1 site 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 1 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Xunming Ji, MD (010-83198952, jixm@ccmu.edu.cn), 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 28 Jan 2022.