Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-08

Study Completion Date

2029-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Balloon Angioplasty vs Stenting Following Residual Stenosis After Endovascular Treatment of Intracranial Atherosclerotic Acute Ischemic Stroke

NCT07026331

Acute Ischemic Stroke

ACTIVE_NOT_RECRUITING NA

Efficacy of Rescue Stenting/Angioplasty After Failed Thrombectomy for Acute Large Intracranial Vascular Occlusion

NCT07026344

Acute Ischemic Stroke

ACTIVE_NOT_RECRUITING NA

Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion

NCT05902000

Thrombectomy Tandem Occlusion Stroke

RECRUITING NA

Rapid Local Ischemic Postconditioning in Acute Ischemic Stroke

NCT06307743

Acute Ischemic Stroke Mechanical Thrombectomy Ischemic Postconditioning +1 more

NOT_YET_RECRUITING NA

A Randomized Clinical Trial on Urgent Angioplasty for IntraCranial Atherosclerotic Stenosis-related Large-Vessel Occlusion After Mechanical Thrombectomy

NCT06702657

AIS ICAS - Intracranial Atherosclerosis Stroke

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is a multicenter, prospective, open-label, blinded endpoint, randomized controlled trial designed to evaluate the effect of immediate angioplasty (with or without stenting) for AIS with severe ICAS. The primary outcome is the proportion of patients with a 90-day modified Rankin scale (mRS) of 0-2.

Study intervention: (1) Participants in the intervention group will undergo immediate angioplasty (with or without stenting), and will receive the best medical treatment (BMT) after the procedure. (2) Participants in the control group will receive BMT alone.

This study is anticipated to enroll 412 participants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The intervention group

Participants will receive immediate angioplasty (with or without stenting) for the culprit vessel and the target residual stenosis should be less than 50%. All participants will receive the best medical treatment (BMT).

Group Type EXPERIMENTAL

Immediate angioplasty

Intervention Type PROCEDURE

See arm/group descriptions.

The control group

Participants will receive BMT alone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Immediate angioplasty

See arm/group descriptions.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 18 years or older.
2. Diagnosed with AIS and baseline NIHSS ≥6.
3. Pre-stroke mRS ≤2.
4. Time from symptom onset to randomization ≤ 24 hours; the onset time refers to "Last Known Well" (LKW).
5. Non-contrast CT ASPECTS score ≥6.
6. CTA confirmed severe ICAS (70-99%) of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery, and is presumed to be responsible for the stroke.
7. Informed consent signed by the patient or authorized representative.

Exclusion Criteria

1. Normal diameter of the culprit vessel \<2.0 mm.
2. Isolated perforator artery infarction (except for combined cortical hypoperfusion).
3. Hemorrhagic stroke within the past 90 days.
4. Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, traumatic dissection, etc..
5. Severe calcification at the stenosis site, where expected residual stenosis ≤50% cannot be achieved with procedure.
6. Known cardiac thrombus source (e.g., atrial fibrillation, patent foramen ovale, infective endocarditis).
7. INR \>1.7 when using warfarin; coagulation dysfunction or uncorrectable bleeding factors.
8. Platelet count \<50×10\^9/L.
9. Intracranial hemorrhage confirmed by CT or MRI.
10. Women who are pregnant or breastfeeding.
11. Participation in other intervention clinical trials.
12. Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
13. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
14. Aortic dissection.
15. Concomitant intracranial tumor (except for meningioma \<10mm) or arteriovenous malformation.
16. Severe vascular tortuosity, difficult access for intervention, or inability to complete endovascular treatment.
17. Any active bleeding or recent bleeding in the last 1 month.
18. SBP\>185 mmHg or DBP\>110 mmHg refractory to treatment.
19. Anticipated life expectancy \<3 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
20. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No