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New treatment option for Carotid Artery Stenosis
Official title Study on the Trans-Carotid Artery Occlusion Shunt System Combined With Introducer Sets
ClinicalTrials.gov ID: NCT06959628
What this study is testing
- What it's testing
- The objective of the study is to evaluate the Safety and Efficacy of the Trans-Carotid Artery Occlusion Shunt System Combined with Introducer Sets for Cerebral Protection During Carotid Angioplasty
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Patients with internal carotid artery stenosis, meeting at least one of the following conditions:
- Asymptomatic carotid artery stenosis: Stenosis severity \> 70%;
- Symptomatic carotid artery stenosis: Stenosis severity \> 50%, with one or more of the following symptoms occurring within 180 days prior to the...
- Common carotid artery diameter \> 6 mm, and meets the required vascular diameter for carotid artery stenting;
You likely can't join if
- Anatomical Exclusion Criteria:
- Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;
- Patients with lesions in the common carotid artery access area or its proximal segment;
- Patients with the common carotid artery bifurcation located \< 5 cm from the clavicular margin;
- Patients with tandem severe stenosis or occlusion at the target lesion site;
- Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;
See the full eligibility criteria
Who can join
- Age ≥ 18 years;
- Patients with internal carotid artery stenosis, meeting at least one of the following conditions:
- Asymptomatic carotid artery stenosis: Stenosis severity \> 70%;
- Symptomatic carotid artery stenosis: Stenosis severity \> 50%, with one or more of the following symptoms occurring within 180 days prior to the procedure: transient ischemic attack (TIA), transient visual obscurations...
- Common carotid artery diameter \> 6 mm, and meets the required vascular diameter for carotid artery stenting;
- The participant or their legal guardian is able to understand the purpose of the trial, voluntarily consent to participation, sign an informed consent form, and is willing to comply with follow-up requirements as...
What rules you out
- Anatomical Exclusion Criteria:
- Patients with extensive atherosclerotic plaques in the proximal common carotid artery, which hinder safe surgical manipulation;
- Patients with lesions in the common carotid artery access area or its proximal segment;
- Patients with the common carotid artery bifurcation located \< 5 cm from the clavicular margin;
- Patients with tandem severe stenosis or occlusion at the target lesion site;
- Patients who have previously received stent or graft implantation in the ipsilateral carotid artery;
- Patients with bilateral carotid artery stenosis requiring intervention on both sides;
- Patients with acute or subacute thrombosis, arteriovenous malformations, or other abnormal vascular structures in the target lesion or adjacent regions;
- Patients with severe calcification or tortuosity at the target lesion site, making it difficult to deliver devices to the intended location;
- Patients with concomitant severe symptomatic stenosis in other vascular territories, including intracranial or extracranial arteries;
- Patients who have experienced an ischemic stroke within the past 3 months, which may impact endpoint evaluation;
- Patients with a history of spontaneous intracranial hemorrhage within the past 12 months;
- Patients diagnosed with carotid artery dissection;
- Patients with carotid stenosis due to non-atherosclerotic causes;
- Patients with other cardiovascular conditions that may predispose to embolism, including left ventricular aneurysm, cardiomyopathy, mechanical aortic or mitral valves, infective endocarditis, mitral stenosis, atrial...
- Patients with central nervous system disorders, including cranial nerve impairment, which could confound endpoint evaluation (e.g., severe dementia, secondary epilepsy, etc.);
- Patients with chronic atrial fibrillation;
- Patients with paroxysmal atrial fibrillation episodes within the past 6 months or those requiring long-term anticoagulation therapy due to paroxysmal atrial fibrillation;
- Patients who have had a myocardial infarction within the last 6 months;
- Patients who have undergone or plan to undergo coronary artery bypass grafting (CABG), endovascular stenting procedures, or heart valve surgeries within 90 days prior to the procedure, which may interfere with endpoint...
- Patients with active bleeding tendencies or significant coagulation disorders;
- Patients with a history of gastrointestinal bleeding that could interfere with antiplatelet therapy;
- Patients with preoperative liver or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels exceeding 5 times the upper limit of normal, or serum creatinine (Cr) \> 3.0...
- Patients with known hypersensitivity to contrast agents, anticoagulants, antiplatelet medications, or materials used in stent delivery systems (e.g., nitinol, PTFE, nylon-based polymers);
- Patients with intracranial or other malignancies;
- Patients with a life expectancy of less than 3 years;
- Women who are planning pregnancy, pregnant, or breastfeeding;
- Patients participating in another clinical trial or those who have not withdrawn or been excluded from a trial within the last 3 months of the screening period;
- Other patients who, in the investigator's opinion, are deemed unsuitable for inclusion in the study
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, 18 years and older. 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.