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Tests treatment safety and results for Asymptomatic Carotid Artery Stenosis
Official title Efficacy and Safety Study of Endovascular Treatment of Asymptomatic Carotid Artery Stenosis
ClinicalTrials.gov ID: NCT06899399
What this study is testing
What is Best medical treatment?
Best medical treatment is an investigational medicine, being studied as a potential treatment for asymptomatic carotid artery stenosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, prospective, open-label, endpoint-blinded, randomized controlled trial designed to evaluate the safety and efficacy of endovascular stenting combined with optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic severe stenosis (70-99%) of the internal carotid artery. The study plans to enroll 982 patients aged 40-80 years who have had no ipsilateral carotid artery-related neurological symptoms in the past six months and who have declined carotid endarterectomy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Age 40-80 years
- Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
- Contralateral ICA stenosis \<70%
- No TIA/stroke related to target lesion in past 6 months
- Declined carotid endarterectomy
You likely can't join if
- symptomatic internal carotid artery stenosis in the past 6 months
- Spontaneous intracranial hemorrhage in nearly one year
- Patients with larger intracranial aneurysms (diameter \>5 mm) who cannot undergo prior or concurrent treatment
- Chronic occlusion without obvious symptoms of cerebral ischemic attack
- Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
- Common carotid artery ostial lesion
See the full eligibility criteria
- Age 40-80 years
- Severe asymptomatic internal carotid artery stenosis (70-99%) confirmed by ultrasound/CTA/DSA
- Contralateral ICA stenosis \<70%
- No TIA/stroke related to target lesion in past 6 months
- Declined carotid endarterectomy
- Willing to complete 12-month follow-up
- Signed informed consent by participant/legal representative
- symptomatic internal carotid artery stenosis in the past 6 months
- Spontaneous intracranial hemorrhage in nearly one year
- Patients with larger intracranial aneurysms (diameter \>5 mm) who cannot undergo prior or concurrent treatment
- Chronic occlusion without obvious symptoms of cerebral ischemic attack
- Patients with transient or permanent neurological deficit resulting from Neurological deficits mimicking TIA/stroke from TIA or stroke
- Common carotid artery ostial lesion
- Tandem lesions with severe stenosis of the ipsilateral intracranial artery
- Patients with severe dementia
- Internal carotid artery dissection
- Internal carotid artery aneurysm
- Myocardial infarction within 30 days
- Ejection fraction \<30% or New York Heart Association (NYHA) functional class III or higher; unstable angina, characterized by angina at rest with electrocardiogram changes
- Cardiogenic embolism, including left ventricular aneurysm, intraluminal filling defects, cardiomyopathy, aortic or mitral valve-prosthetic heart valve, calcified aortic stenosis, infective endocarditis
- Mitral stenosis, atrial septal defect, atrial septal aneurysm or left chamber myxoma
- Two or more proximal or main coronary artery stenosis 70%, untreated or recanable
- Platelets \ 1.5, bleeding time\> 1min or heparin-related thrombocytopenia; heparin is a contraindication to antiplatelet drugs; coagulopathy
- Poor controlled diabetes mellitus, fasting blood glucose\> 22 mmol/L and ketone body\>+2
- Malignant tumor or respiratory insufficiency, and a life expectancy of \<5 years
- Severe liver and kidney function impairment, ALT\> 3 times the upper limit of normal value or AST\> 3 times the upper limit of normal value, blood creatinine increase\> 2 times the upper limit of normal value
- Contrast allergy
- Other general anesthesia operations are required during the same period
- Pregnant or lactating women
- The patient does not attend the clinical trial of other drug or medical device before enrollment
- The investigator is not considered fit to participate in this clinical study Imaging exclusion criteria:
- Type III aortic arch
- Severe angulation or tortuosity (≥90 degrees) of the common carotid artery or innominate artery that prevents safe and rapid placement of a guiding catheter or long sheath
- Severe angulation or tortuosity of the internal carotid artery that prevents safe deployment of an embolic protection device or stent. Severe tortuosity is defined as the presence of two or more angles ≥90 degrees...
- Stenosis of the beginning or proximal end of the common carotid artery, innominate artery, distal or intracranial segment of the internal carotid artery, and the stenosis degree is greater than that of the target...
- The stenotic lesion exhibits severe circumferential calcification, defined as calcification greater than 3 mm in thickness visible in orthogonal views during fluoroscopy. (Note: In elderly people aged ≥70 years...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.