Endovascular ThrombectomyNCT06094569
Medical Imaging Screening for Posterior-circulation Ischemic Stroke
An observational study of Endovascular Thrombectomy, run by Tianjin Huanhu Hospital at 4 sites in China.
Trial summary
Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endovascular Thrombectomy
- What is being tested?
- Endovascular Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2019to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All acute ischemic strvoke patients with vertebrobasilar artery occlusion.
Who may be able to join
- Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;
- Patients with acute ischemic stroke recently；
- Symptoms persisted at admission, and MRI (including DWI) confirmed acute ischemic vertebrobasilar artery occlusion in the posterior circulation:（single right or left intracranial branch of vertebral artery occlusion ; single basilar occlusion ; both two vertebral arterys and basilar artery）；
Who cannot join
- 1.Patiens can not meet the MRI examination conditions(with absolute and relative contraindications).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Xuanye Yue, MD, 022-60814622, yuexy2002@aliyun.com
Xuanye Yue, MD
- Recruiting
The Sencond Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300211
Zhenjian Ma, MD, 18322412226, mazhenjian@126.com
Zhenjian Ma, MD
- Recruiting
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, 300222
Ming Wei, PhD, 13502182903, drweiming@163.com
Ming Wei, PhD
- Recruiting
Beijing University Binhai Hospital
Tianjin, Tianjin Municipality, 300450
Wanchao Shi, MD, 15620177339, swc9801@sina.com
Wanchao
About this study
Official title: Medical Imaging Screening for Posterior-circulation Ischemic Stroke：a Multicentre,Imaging-based,Prospective Cohort Study
Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. We assess the degree of ischemia by defining the pons-midbrain-medulla index (PMMI) and correlate the preoperative PMMI with the clinical prognosis of postoperative patients to verify the validity of PMMI in predicting the clinical prognosis of patients with embolization.
Read the detailed description
- The ENDOSTROKE registry (Endovascular Stroke T reatment Registry), the use of MRI before EVT was associated with significantly better clinical outcomes as compared to CT.
- The purpose of the study will sift patients with posterior circulation ischemia stroke who will get better outcome by Mechanical Thrombectomy by neuroimaging.Specifically, the following assumption will be evaluated: the modified pons-midbrain index in magnetic resonance imaging can predict the clinical outcome of patients with basilar artery thrombosis 90 days after surgery, and can guide whether patients will undergo mechanical thrombectomy later.
- Pons-midbrain-medulla index (PMMI) : We divide pons-midbrain-medulla into the left and right sides by the median line of the brainstem,so we will evaluate ischemia of these six layers which are endowed different score according to the degree of ischemia. Instead of the previous pons-midbrain index (PMI), we select the image layer that shows the largest infarct size among the six parts.Then,we add up six scores that is patient's PMMI. Scoring criteria: At the layer of displaying the maximum infarct size, 2 points are scored if the infarct size exceeds 50% of the total area, 1 point is scored if the infarct size is less than 50% of the total area, and 0 points are scored if there is no infarct.Finally, PMMI values range from 0 to 12 points.
- The investigators conduct a multicenter, prospective cohort study.Preoperative images of patients are evaluated by different groups of imaging physicians to describe the association between preoperative PMMI and clinical prognosis in patients with posterior circulation stroke and to verify its validity.
- Conditions
- Endovascular Thrombectomy
- Being tested
- Endovascular Therapy
- Keywords
- select patients, endovascular thrombectomy, magnetic resonance imaging, diffusion weighted imaging, Vertebrobasilar artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular TherapyProcedure or surgery
Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices
| Study group | Role | What they receive |
|---|---|---|
| Endovascular therapy | Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods. Receives: Procedure: Endovascular Therapy | |
| Best medical management | Patients enrolled in this group received the best medical management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified ranking scale (mRS) at 90 days
A 0-6 scale running from perfect health without symptoms to death.
Measured: 90 days
Secondary outcomes (1)
Mortality within 90 days
mortality of any causes.
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 posted23 Oct 2023
- Study start1 Jun 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular ThrombectomyStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094569
- Sponsor's protocol ID
- TJHH-2023-wm14
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Imaging Screening for Posterior-circulation Ischemic Stroke：a Multicentre,Imaging-based,Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06094569
- Acronym / sponsor ID
- TJHH-2023-wm14
- Conditions
- Endovascular Thrombectomy
- Keywords
- select patients, endovascular thrombectomy, magnetic resonance imaging, diffusion weighted imaging, Vertebrobasilar artery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Oct 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.
Patients with ischemic stroke in the posterior circulation continue to have high rates of mortality and disability, even with aggressive treatment. We wanted to evaluate preoperative imaging to screen patients with a good prognosis from mechanical embolization. We assess the degree of ischemia by defining the pons-midbrain-medulla index (PMMI) and correlate the preoperative PMMI with the clinical prognosis of postoperative patients to verify the validity of PMMI in predicting the clinical prognosis of patients with embolization.
Detailed description
- The ENDOSTROKE registry (Endovascular Stroke T reatment Registry), the use of MRI before EVT was associated with significantly better clinical outcomes as compared to CT.
- The purpose of the study will sift patients with posterior circulation ischemia stroke who will get better outcome by Mechanical Thrombectomy by neuroimaging.Specifically, the following assumption will be evaluated: the modified pons-midbrain index in magnetic resonance imaging can predict the clinical outcome of patients with basilar artery thrombosis 90 days after surgery, and can guide whether patients will undergo mechanical thrombectomy later.
- Pons-midbrain-medulla index (PMMI) : We divide pons-midbrain-medulla into the left and right sides by the median line of the brainstem,so we will evaluate ischemia of these six layers which are endowed different score according to the degree of ischemia. Instead of the previous pons-midbrain index (PMI), we select the image layer that shows the largest infarct size among the six parts.Then,we add up six scores that is patient's PMMI. Scoring criteria: At the layer of displaying the maximum infarct size, 2 points are scored if the infarct size exceeds 50% of the total area, 1 point is scored if the infarct size is less than 50% of the total area, and 0 points are scored if there is no infarct.Finally, PMMI values range from 0 to 12 points.
- The investigators conduct a multicenter, prospective cohort study.Preoperative images of patients are evaluated by different groups of imaging physicians to describe the association between preoperative PMMI and clinical prognosis in patients with posterior circulation stroke and to verify its validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular therapy | – | Procedure: Endovascular TherapyTimely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombus aspiration, others, or combination methods. |
| Best medical management | – | –Patients enrolled in this group received the best medical management. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All acute ischemic strvoke patients with vertebrobasilar artery occlusion.
Key inclusion criteria (3 listed)
- Patient admitted from Jun. 1st 2019 to Jan. 1st 2029;
- Patients with acute ischemic stroke recently；
- Symptoms persisted at admission, and MRI (including DWI) confirmed acute ischemic vertebrobasilar artery occlusion in the posterior circulation:（single right or left intracranial branch of vertebral artery occlusion ; single basilar occlusion ; both two vertebral arterys and basilar artery）；
Key exclusion criteria (1 listed)
- 1.Patiens can not meet the MRI examination conditions(with absolute and relative contraindications).
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 TherapyEndovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices | Procedure or surgery | Endovascular therapy |
Primary outcome
Modified ranking scale (mRS) at 90 days
Time frame: 90 days
A 0-6 scale running from perfect health without symptoms to death.
1 secondary outcome
Mortality within 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
4 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 Thrombectomy, run by Tianjin Huanhu Hospital at 4 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 3 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: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Wei, PhD (13502182903, drweiming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified ranking scale (mRS) 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 23 Oct 2023.