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Official title Study on the Trans-Carotid Artery Occlusion Shunt System
ClinicalTrials.gov ID: NCT06924593
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 for Carotid Artery Revascularization during Endovascular Treatment
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;
- For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following...
- Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 50%, and the patient has a...
- Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 70%, and the patient has...
- The modified Rankin Scale (mRs) score ≤ 2 before enrollment.
You likely can't join if
- Anatomical exclusion criteria: There are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion...
- Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);
- Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);
- The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;
- There has been spontaneous intracranial hemorrhage within 12 months;
- Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);
See the full eligibility criteria
Who can join
- Age \> 18 years;
- For patients diagnosed with carotid artery stenosis and planned to undergo transcarotid artery endovascular revascularization, one of the following conditions must be met:
- Symptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 50%, and the patient has a history of stroke (mild or non-disabling), transient ischemic attack...
- Asymptomatic carotid artery stenosis: The degree of stenosis is determined by non-invasive imaging or angiography to be \> 70%, and the patient has not experienced any neurological symptoms within 180 days before the...
- The modified Rankin Scale (mRs) score ≤ 2 before enrollment.
- The patient must meet at least one of the following important anatomical or comorbid high-risk conditions in order to be included in the study: Anatomical high-risk: A. Contralateral carotid artery occlusion; B...
- The diameter of the common carotid artery on the target lesion side is \> 6 mm;
- The patient is able to understand the purpose of the trial, voluntarily participates in this study, signs the informed consent form, and is willing to complete the follow-up according to the requirements of the protocol.
What rules you out
- Anatomical exclusion criteria: There are extensive atherosclerotic plaques in the proximal part of the common carotid artery on the target lesion side, making the safe operation of the surgery difficult; There are...
- Known to have uncontrollable hypertension (systolic blood pressure continuously ≥ 180 mmHg or diastolic blood pressure continuously ≥ 110 mmHg);
- Combined with symptomatic severe stenosis of other blood vessels (including intracranial and extracranial vessels);
- The patient has experienced an ischemic stroke within 3 months, and the stroke affects the evaluation of the endpoints;
- There has been spontaneous intracranial hemorrhage within 12 months;
- Carotid artery stenosis not caused by atherosclerosis (such as dissection, fibromuscular dysplasia, etc.);
- There are other heart diseases that may lead to embolism: such as left ventricular aneurysm, intracardiac filling defect, cardiomyopathy, artificial aortic valve or artificial mitral valve, calcific aortic stenosis...
- Severe dementia or other nervous system diseases that may interfere with the evaluation of neurological function;
- Advanced heart failure;
- Chronic atrial fibrillation; Paroxysmal atrial fibrillation with an episode within 6 months or paroxysmal atrial fibrillation requiring long-term anticoagulant therapy;
- Myocardial infarction occurred within 72 hours before the operation;
- Coronary artery bypass grafting (CABG), endovascular stent surgery, cardiac valve surgery or vascular surgical procedures have been or will be performed within 30 days before and after the operation;
- There is an active bleeding tendency or severe coagulation dysfunction; There has been gastrointestinal bleeding within 30 days before the operation, which will affect antiplatelet therapy;
- Hemoglobin (Hgb) \< 8 gm/dL, platelet count \< 90×10\^9/L or a history of heparin-induced thrombocytopenia;
- Patients with abnormal liver and kidney function before the operation [Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) exceeding 5 times the upper limit of the normal value; Serum creatinine (Cr) \>...
- Patients known to be allergic to contrast agents, stent and delivery device materials (referring to nitinol, PTFE, nylon polymer materials); Patients known to have contraindications to anticoagulant and antiplatelet...
- Intracranial tumors or other malignant tumors;
- Life expectancy is less than 1 year;
- Women who plan to become pregnant, are pregnant or are breastfeeding;
- Patients who are participating in other clinical trials at the same time and have not withdrawn from the trials;
- Patients who are judged by the researcher as not suitable for participating in this clinical trial.
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.