Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis (NCT06365697) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis
China188 participantsStarted 2024-04-24
Plain-language summary
The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patient is 18-80 years old and of any sex;
* Patient is diagnosed with carotid atherosclerotic stenosis by imaging. The lesion site is located in the extracranial segment of carotid artery and is suitable for endovascular treatment. Patient is either symptomatic with carotid stenosis≥50% or asymptomatic with carotid stenosis≥70% as determined by digital subtraction angiography (DSA) using NASCET methodology.
* Symptomatic is defined as non-disabling ischemic stroke (mRS≤2) or transient cerebral ischemia (TIA, including cerebral hemispheric neurological events and amaurosis fugax) associated with the carotid stenosis within the past 6 months.
* The target vessel reference diameter ranges from 3.5mm to 9mm.
* Patient has been informed of the nature of this trial, understood the purpose of this clinical investigation, and volunteered to participate and sign the informed consent form.
Exclusion Criteria:
* Evolving stroke within 3 months before index procedure, disabling stroke (mRS≥3) before the procedure, or massive cerebral infarction (area of infarction is \>1/3 of the ipsilateral middle cerebral artery territory) within 30 days before the procedure.
* Myocardial infarction within 30 days prior to index procedure.
* Severe heart, lung, liver, or renal insufficiency.
* Patient has known bleeding diathesis, or contraindication to heparin or antiplatelet therapy.
* Patient has a known allergy to contrast media or nickel-titanium material.
* Disturbanc…
What they're measuring
1
Incidence of non-MAE(major adverse events) within 30 days post-procedure