Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06557135
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis \>50%; asymptomatic stenosis \>70%)
* Aged 18 or above
* With palpable brachial and femoral arteries
* The patient or his/her agent understands the purpose and needs of this study and signs the informed consent
Exclusion Criteria:
* Symptomatic stenosis or occlusion of multiple vessels at the same time
* Intravascular intervention for multiple vessel lesions at the same time
* Ischemic stroke within the past 2 weeks
* Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin \< 10g/dL, or platelet count \< 100,000 /μ L, or unadjusted INR \>1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia
* A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint
* A history of cerebral hemorrhage in the past six months
* Any condition that may interfere with digital subtraction angiography (DSA) or cause unsafe percutaneous arterial access Participating in other clinical trials, in the research stage or follow-up stage
* Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency
* Unable to understand or sign the informed consent form
* Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery
* Baseline modified Rankin scale greater than or equal to 2
* Expected survival is less than 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06557135
Study Brief:
Protocol Section:
NCT06557135