Actively Recruiting
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-05-25
412
Participants Needed
2
Research Sites
238 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
S
Shenzhen Hospital of Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with acute ischemic stroke (AIS) and baseline NIH Stroke Scale (NIHSS) score of 6 or higher
- Pre-stroke modified Rankin Scale (mRS) score of 2 or less
- Time from symptom onset to randomization is 24 hours or less, based on last known well time
- Non-contrast CT ASPECTS score of 6 or higher
- CTA confirmed severe intracranial atherosclerotic stenosis (70-99%) in specified brain arteries responsible for the stroke
- Signed informed consent by patient or authorized representative
You will not qualify if you...
- Diameter of the culprit blood vessel less than 2.0 mm
- Isolated perforator artery infarction except if combined with cortical hypoperfusion
- Hemorrhagic stroke within the past 90 days
- Cerebrovascular conditions such as vasculitis, moya-moya disease, arterial inflammatory stenosis, vasospasm, or traumatic dissection
- Severe calcification at stenosis site preventing adequate procedure results
- Known cardiac sources of thrombus like atrial fibrillation or infective endocarditis
- INR greater than 1.7 when on warfarin or uncorrectable bleeding disorders
- Platelet count below 50 x 10^9/L
- Intracranial hemorrhage confirmed by CT or MRI
- Pregnant or breastfeeding women
- Participation in other intervention clinical trials
- Severe kidney insufficiency with low filtration rate or high blood creatinine
- Severe allergy to contrast agents or absolute contraindication to iodine contrast
- Aortic dissection
- Presence of intracranial tumor (except small meningioma <10mm) or arteriovenous malformation
- Severe vascular tortuosity or inability to complete endovascular treatment
- Active bleeding or recent bleeding within the last month
- Uncontrolled high blood pressure (SBP >185 mmHg or DBP >110 mmHg) despite treatment
- Life expectancy less than 3 months due to serious illness
- Any condition judged by investigators to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
2
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
X
Xinguang Yang, M.D.
CONTACT
X
Xiongjun He, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here