StrokeNCT06236828
The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
An observational study of Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute Ischemic Stroke, Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2023to 1 Nov 2023
- 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: From January 2020 to September 2022, ABAO patients at Xuanwu Hospital Capital Medical University and 10 branch centers underwent EVT or SMT.
Who may be able to join
- Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations.
- Confirmation through CTA/MRA/DSA that there is occlusion of the basilar artery or the V4 segment of the vertebral artery leading to functional occlusion of the basilar artery.
- Age 18 years and older.
- Symptom onset within 24 hours.
- Having a baseline MRI evaluation, including at least DWI and T2 FLAIR sequences (baseline MRI for the EVT group before the operation; baseline MRI for the SMT group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline MRI for the SMT group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible).
Who cannot join
- mRS score ≥ 3 before onset;
- Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present;
- Lack of follow-up results within 90 days after operation;
- Life expectancy < 3 months;
- Baseline imaging and crucial clinical data are missing;
- Special cases involving pregnancy and lactation;
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- Severe systemic diseases or advanced cancer that may potentially interfere with the prognosis;
- Allergic reactions to contrast agents or nickel-titanium alloys;
- Currently participating in other clinical trials;
- Pre-existing neurological disorders or psychiatric conditions that could affect the assessment of the disease.
Trial locations and contacts
1 site in 1 country.
About this study
Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs).
Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.
- Conditions
- Stroke, Acute Ischemic Stroke, Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Keywords
- MRI, Endovascular Thrombectomy, Standard Medical Therapy, Large Vessel Occlusion, Acute Basilar Artery Occlusion
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyDevice
The endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Thrombectomy | For patients who onset within 4.5 hours and meet the criteria for intravenous thrombolysis treatment, they could receive intravenous thrombolysis treatment beforehand and bridging to endovascular therapy. Receives: Device: Mechanical Thrombectomy | |
| Standard Medical Therapy | For patients who onset within 4.5 hours and met the criteria for intravenous thrombolysis treatment, recombinant tissue plasminogen activator (rt-PA) or urokinase, and other intravenous thrombolysis therapies should be pre-administrated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days after EVT or SMT
Secondary outcomes (9)
Mortality
Death defined as a mRS score of 6
Measured: 90 days after EVT or SMT
Rate of mRS score of 0-2
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days after EVT or SMT
Improvement of mRS score
The mRS score range from 0 (no disability) to 6 (death)
The mRS score range from 0 (no disability) to 6 (death)
Measured: 90 days after EVT or SMT
Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline
The NIHSS score range from 0 (no deficit) to 42 (maximum deficit).
Measured: 24 hours and 5-7 days (or at discharge) after EVT
Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group
Measured: Immediately after the completion of endovascular therapy.
Rate of Intracranial hemorrhage (ICH)
Measured: Within 72 hours after EVT or SMT
Rate of symptomatic intracranial hemorrhage (sICH)
The sICH was assessed based on the Heidelberg Bleeding Classification, defined as 1) ≥4 points total NIHSS at the time of diagnosis compared to immediately before worsening; 2) ≥2 point in one NIHSS category. The rationale for this is to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; 3) Leading to intubation/hemicraniectomy/EVD placement or other major medical/surgical intervention; 4) Absence of alternative explanation for deterioration.
Measured: Within 72 hours after EVT or SMT
Rate of non-hemorrhage severe adverse event
ulmonary infection, respiratory failure, heart failure, myocardial infarction, urinary infection, etc.
Measured: Within 72 hours after EVT or SMT
Surgical instrument-related Complications
Vascular perforation, arterial dissection, arterial embolism, or distal embolism, etc.
Measured: Within 72 hours after EVT or SMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start31 Jan 2023
- Primary completion1 Jul 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236828
- Sponsor's protocol ID
- MR-EPICS
- Status last verified
- Jan 2023
- First submitted
- 29 Nov 2023
- Last updated
- 1 Feb 2024
- 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 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MRI-based Evaluation of Safety and Efficacy of EVT and SMT: A Retrospective, Multicenter Study
- ClinicalTrials.gov ID
- NCT06236828
- Acronym / sponsor ID
- MR-EPICS
- Conditions
- Stroke, Acute Ischemic Stroke, Ischemic Stroke
- Keywords
- MRI, Endovascular Thrombectomy, Standard Medical Therapy, Large Vessel Occlusion, Acute Basilar Artery Occlusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 Feb 2024 (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.
Acute Basilar Artery Occlusion (ABAO), a condition with a high risk of mortality or disability (up to 80%). The safety and efficacy of endovascular thrombectomy (EVT) in ABAO remains uncertain due to inconsistent evidence from random controlled trials (RCTs).
Recent studies have explored the use of MRI in ABAO, this study aims to assess the efficacy and safety of EVT and standard medical therapy (SMT) in the treatment of ABAO within 24 hours of onset. It also aims to explore the feasibility and prognostic value of MRI-based assessment of ABAO infarction using AI image analysis software.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Thrombectomy | – | Device: Mechanical ThrombectomyFor patients who onset within 4.5 hours and meet the criteria for intravenous thrombolysis treatment, they could receive intravenous thrombolysis treatment beforehand and bridging to endovascular therapy. |
| Standard Medical Therapy | – | –For patients who onset within 4.5 hours and met the criteria for intravenous thrombolysis treatment, recombinant tissue plasminogen activator (rt-PA) or urokinase, and other intravenous thrombolysis therapies should be pre-administrated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From January 2020 to September 2022, ABAO patients at Xuanwu Hospital Capital Medical University and 10 branch centers underwent EVT or SMT.
Key inclusion criteria (5 listed)
- Preliminary diagnosis of posterior circulation ischemic stroke based on clinical symptoms or imaging examinations.
- Confirmation through CTA/MRA/DSA that there is occlusion of the basilar artery or the V4 segment of the vertebral artery leading to functional occlusion of the basilar artery.
- Age 18 years and older.
- Symptom onset within 24 hours.
- Having a baseline MRI evaluation, including at least DWI and T2 FLAIR sequences (baseline MRI for the EVT group before the operation; baseline MRI for the SMT group within the treatment window (within 4.5 hours of onset) for thrombolytic patients before or during the thrombolysis process should initiate as early as possible; baseline MRI for the SMT group for extended treatment window patients (between 4.5 hours to 12 hours of onset) should initiate as early as possible).
Key exclusion criteria (10 listed)
- mRS score ≥ 3 before onset;
- Significant neuroimaging changes such as cerebral hemorrhage, cerebellar mass lesion, acute hydrocephalus, etc., are present;
- Lack of follow-up results within 90 days after operation;
- Life expectancy < 3 months;
- Baseline imaging and crucial clinical data are missing;
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 |
|---|---|---|
| Mechanical ThrombectomyThe endovascular mechanical thrombectomy methods mainly include stent retriever thrombectomy, ADAPT thrombus aspiration technique, or their combination. | Device | Endovascular Thrombectomy |
Primary outcome
Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days
Time frame: 90 days after EVT or SMT
The mRS score range from 0 (no disability) to 6 (death)
9 secondary outcomes
Mortality
Time frame: 90 days after EVT or SMT
Rate of mRS score of 0-2
Time frame: 90 days after EVT or SMT
Improvement of mRS score
Time frame: 90 days after EVT or SMT
Change of the National Institutes of Health Stroke Scale (NIHSS) score comparing to baseline
Time frame: 24 hours and 5-7 days (or at discharge) after EVT
Rate of successful revascularization (mTICI 2b-3) in target blood vessels of EVT group
Time frame: Immediately after the completion of endovascular therapy.
Rate of Intracranial hemorrhage (ICH)
Time frame: Within 72 hours after EVT or SMT
Rate of symptomatic intracranial hemorrhage (sICH)
Time frame: Within 72 hours after EVT or SMT
Rate of non-hemorrhage severe adverse event
Time frame: Within 72 hours after EVT or SMT
Surgical instrument-related Complications
Time frame: Within 72 hours after EVT or SMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Stroke and Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing 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 5 inclusion and 10 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: finished, as of the sponsor's last update on 1 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of modified Rankin Scale (mRS) score of 0-3 at 90 days (time frame: 90 days after EVT or SMT). 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 1 Feb 2024.