Endovascular TreatmentMild-MTNCT06464731
Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation
A study testing EVT in people with Endovascular Treatment and Mild Stroke, run by Wen-huo Chen at 9 sites in China.
Trial summary
Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endovascular Treatment, Mild Stroke
- What is being tested?
- EVT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jan 2017to 30 Dec 2024
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old;
- Symptoms onset or last known well to randomization is within 24 hours.
- Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery [ICA], middle cerebral artery [MCA] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;
- Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
- ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization;
Who cannot join
- Premorbid Rankin Scale (mRS) score ≥ 1;
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
- Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);
- Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
- Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
- Known bleeding tendencies, including but not limited to platelet count <100×109/L; received heparin treatment within 48 hours with an activated partial thromboplastin time (APTT) ≥35s; recent oral anticoagulant therapy with international normalized ratio (INR) >3; Note: Patients without a history of coagulation abnormalities or without suspicion of coagulation abnormalities do not need to wait for laboratory test results before enrollment;
Show all 15Show fewer
- Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;
- Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;
- Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;
- Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;
- Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;
- Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;
- Aortic dissection;
- Multiple intracranial large vessel occlusions confirmed by CTA or MRA, unable to clearly identify the symptomatic vessel, such as bilateral MCA occlusions or occlusions involving both the MCA and basilar artery;
- Suspected or confirmed occluded artery is non-acute occlusion.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 330000
Guoyong Zeng, MD, 13507079530, hsyygy@163.com
- Recruiting
Jiamusi Central Hospital
Jiamusi, Heilongjiang, 154000
Li-hua Xu, MD, 13846178333, drxulihua@163.com
- Recruiting
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, 730050
Ya Shao, MD, 18919810265, shaoya20042001@126.com
- Recruiting
Lishui Central Hospital
Lishui, Zhejiang, 310000
Xueli Cai, 13967059836, mailto:xueli_cai_official@126.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaobing Li, MD, 13970935284, lxb0203208@126.com
- Recruiting
Shenyang First People's Hospital
Shenyang, Liaoling
Yi Sui, MD, 13998352587, tjyiia@hotmail.com
- Recruiting
Songyuan Jilin Oilfield Hospital
Songyuan, Jilin, 138000
Dongsheng Ju, 13894158599, judongsheng_1981@163.com
- Recruiting
Taizhou First People's Hospital
Taizhou, Zhejiang, 310000
Chenghua Xu, 15857655838, samuel5098@163.com
- Recruiting
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, 363000
Tingyu Yi, MD, 15859635985, siyuyufen@163.com
About this study
Official title: Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry
Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.
Read the detailed description
The purpose of this registry is to select patients with mild AIS caused by anterior circulation LVO with mismatched volume of the ischemic penumbra based on screen of cerebral perfusion imaging. This registry aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.
- Conditions
- Endovascular Treatment, Mild Stroke
- Being tested
- EVT
- Keywords
- endovascular treatment, mild stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVTProcedure or surgery
Also called Experimental
Interventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The operator will choose the optimal endovascular treatment strategy and device based on the patient's condition and clinical experience. This may include, but is not limited to, stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc. The endovascular treatment plan and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to current local clinical research standards during and after the procedure. Receives: Procedure: EVT |
| Control Group | No intervention | Patients will receive the best medical treatment according to local clinical research standards, including antiplatelet agents, anticoagulants, thrombolysis, etc., excluding any endovascular treatment. In the event of disease progression defined as neurological deterioration leading to an increase in NIHSS ≥4 points and excluding non-stroke factors within 24 hours, remedial endovascular treatment may be taken, including but not limited to stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of excellent outcome
mRS score 0-1
Measured: 90±7 days
Secondary outcomes (2)
The rate of good outcome
mRS score 0-2
Measured: 90±7 days
mRS shift
distribution of mRS scores
Measured: 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start1 Jan 2017
- Primary completion11 Sep 2024 (estimated)
- Study completion30 Dec 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wen-huo Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wen-huo Chen, Zhangzhou Municipal Hospital
- Investigators
- Tingyu Yi, MD, Principal investigator, Zhangzhou Affiliated Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464731
- Sponsor's protocol ID
- Mild-MT registry
- Acronym
- Mild-MT
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation: A Multicenter Prospective Registry
- ClinicalTrials.gov ID
- NCT06464731
- Acronym / sponsor ID
- Mild-MT / Mild-MT registry
- Conditions
- Endovascular Treatment, Mild Stroke
- Keywords
- endovascular treatment, mild stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wen-huo ChenUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 11 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 18 Jun 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.
Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.
Detailed description
The purpose of this registry is to select patients with mild AIS caused by anterior circulation LVO with mismatched volume of the ischemic penumbra based on screen of cerebral perfusion imaging. This registry aim to explore the efficacy and safety of EVT for mild AIS patients with anterior circulation large vessel occlusion within 24 hours of onset.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: EVTThe operator will choose the optimal endovascular treatment strategy and device based on the patient's condition and clinical experience. This may include, but is not limited to, stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc. The endovascular treatment plan and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to current local clinical research standards during and after the procedure. |
| Control Group | No intervention | –Patients will receive the best medical treatment according to local clinical research standards, including antiplatelet agents, anticoagulants, thrombolysis, etc., excluding any endovascular treatment. In the event of disease progression defined as neurological deterioration leading to an increase in NIHSS ≥4 points and excluding non-stroke factors within 24 hours, remedial endovascular treatment may be taken, including but not limited to stent retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, etc. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old;
- Symptoms onset or last known well to randomization is within 24 hours.
- Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery [ICA], middle cerebral artery [MCA] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;
- Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);
- ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization;
Key exclusion criteria (15 listed)
- Premorbid Rankin Scale (mRS) score ≥ 1;
- Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;
- Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);
- Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);
- Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);
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 |
|---|---|---|
| EVTAlso: ExperimentalInterventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines. | Procedure or surgery | Experimental Group |
Primary outcome
The rate of excellent outcome
Time frame: 90±7 days
mRS score 0-1
2 secondary outcomes
The rate of good outcome
Time frame: 90±7 days
mRS shift
Time frame: 90±7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Endovascular Treatment
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Recruiting
SAIL-MEVO: Endovascular Treatment Versus Best Medical Therapy for Distal Vessel Occlusions
Medium Vessel Occlusion Stroke (MeVO), Stroke Acute
RecruitingObservational study
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
Aortoiliac Occlusive Disease
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.
Tingyu Yi, MD principal investigator
Zhangzhou Affiliated Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVT in people with Endovascular Treatment and Mild Stroke, run by Wen-huo Chen at 9 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 5 inclusion and 15 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 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Wenhuo Chen, MD (+8613806906089, 13806906089@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of excellent outcome (time frame: 90±7 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 18 Jun 2024.