Endovascular Treatment for Mild Stroke With Acute Anterior Circulation Large Vessel Occlusion

NCT ID: NCT06179017

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-07
• Study Completion Date: 2027-12-31

Brief Summary

Exploring the Efficacy and Safety of Emergent Endovascular Treatment in Patients with Mild Ischemic Stroke Caused by Acute Anterior Circulation Large Vessel Occlusion based on Perfusion Imaging Screening

Detailed Description

This study aims to select suitable patients with mild AIS caused by anterior circulation LVO with mismatch volume of the ischemic penumbra based on screen of cerebral perfusion imaging. It is a prospective, multicenter, endpoint-blinded, randomized controlled trial design, and 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group:Endovascular treatment

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.

Group Type: EXPERIMENTAL

Experimental group:Intervention Group

Intervention Type: OTHER

Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines.

Control group: Best medical treatment

Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on.

Group Type: PLACEBO_COMPARATOR

Control group:best medical treatment

Intervention Type: OTHER

Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.

Interventions

Experimental group:Intervention Group

Intervention Group:Interventionist choose the optimal endovascular treatment (EVT) strategy and device based on the patient's condition and local guidelines. The patient will receive the best medical treatment according to the local guidelines.

Intervention Type: OTHER

Control group:best medical treatment

Best medical treatment:Patients will receive the best medical treatment according to local guidelines, including antiplatelet agents, anticoagulants, thrombolysis, etc., but not any EVT. In the control arm, rescue EVT is allowed in patients with disease progression leading to an increase in NIHSS≥4 and excluding the impact of non-stroke factors, and the onset-to-treatment time is within 24 hours.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age 18-80 years old;

2. Symptoms onset or last known well to randomization is within 24 hours.

3. 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) ;

4. Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);

5. ASPECTS score ≥6 based on Non-contrast CT (NCCT) before randomization, and computerized tomography perfusion (CTP) or magnetic resonance imaging perfusion (MRP) imaging presented infarct core volume (relative cerebral blood flow (rCBF) <30%/DWI-ADC<620) ≤50ml, and mismatch volume (Tmax>6 seconds volume - rCBF <30% /DWI-ADC<620) ≥50mL;

6. The patient or their legal representatives voluntarilysigned the informed consent form.

Exclusion Criteria

1. Premorbid Rankin Scale (mRS) score ≥ 1;

2. Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;

3. 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);

4. Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);

5. Baseline blood glucose <50mg/dL (2.78 mmol/L) or >400mg/dL (22.20 mmol/L);

6. 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;

7. Seizures at stroke onset or during the course, hard to accurately judge the baseline NIHSS score;

8. Female who is known to be pregnant, lactation, or tested positive for pregnancy at time of admission;

9. Currently participating in another investigational drug study or medical device treatments that may interfere with the results of this study;

10. Other conditions deemed unsuitable for participation, in the opinion of the investigator, or that may pose significant risks to the patient if participating the study.

1. Evidence of intracranial hemorrhage on CT/MRI, including cerebral parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, and subdural/extradural hemorrhage;

2. Significant midline displacement, hernia of brain, or ventricular mass effect with midline displacement confirmed on CT/MRI;

3. Anticipated impossibility to complete endovascular treatment, such as vascular tortuosity, severe vascular wall calcification, etc.;

4. Aortic dissection;

5. 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;

6. Suspected or confirmed occluded artery is non-acute occlusion.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital Of Guizhou Medical University

OTHER

Sponsor Role: collaborator

Zhangzhou Municipal Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wen-huo Chen

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenhuo Chen, MD

Role: STUDY_DIRECTOR

Zhangzhou Municipal Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University

Locations

Zhangzhou Municipal Hospital

Zhangzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenhuo Chen, MD

Role: CONTACT

13806906089@126.com

+8613806906089

Tingyu Yi, MD

Role: CONTACT

siyuyufen@163.com

+8615859635985

Facility Contacts

Wen-huo Chen, MD

Role: primary

13806906089@126.com

13806906089

References

Sarraj A, Albers GW, Blasco J, Arenillas JF, Ribo M, Hassan AE, de la Ossa NP, Wu TY, Cardona Portela P, Abraham MG, Chen M, Maali L, Kleinig TJ, Cordato D, Wallace AN, Schaafsma JD, Sangha N, Gibson DP, Blackburn SL, De Lera Alfonso M, Pujara D, Shaker F, McCullough-Hicks ME, Moreno Negrete JL, Renu A, Beharry J, Cappelen-Smith C, Rodriguez-Esparragoza L, Olive-Gadea M, Requena M, Almaghrabi T, Mendes Pereira V, Sitton C, Martin-Schild S, Song S, Ma H, Churilov L, Mitchell PJ, Parsons MW, Furlan A, Grotta JC, Donnan GA, Davis SM, Campbell BCV; PERFECT-MILD Collaborators. Thrombectomy versus Medical Management in Mild Strokes due to Large Vessel Occlusion: Exploratory Analysis from the EXTEND-IA Trials and a Pooled International Cohort. Ann Neurol. 2022 Sep;92(3):364-378. doi: 10.1002/ana.26418. Epub 2022 Jul 25.

Reference Type: BACKGROUND

PMID: 35599458 (View on PubMed)

Other Identifiers

MILD-MT

Identifier Type: -

Identifier Source: org_study_id