Status:
UNKNOWN
Radial Versus Femoral Access For Carotid Artery Stenting
Lead Sponsor:
The First Affiliated Hospital of University of Science and Technology of China
Conditions:
Ischemic Stroke
Carotid Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment...
Eligibility Criteria
Inclusion
- General inclusion criteria
- 1\) Age≥18 years old
- Clinical inclusion criteria
- Symptomatic stenosis: patients had a transient ischemic attack (TIA), amaurosis, or minor nondisabling stroke involving the target carotid artery within 180 days before randomization.
- Asymptomatic stenosis: The results of medical history, physical examination and neurological examination do not suggest ischemic symptoms in the target carotid artery. If artery stenosis degree reache the standard, but there are any one or more of the following symptoms including: non-carotid artery symptoms; contralateral carotid artery symptoms; time from symptom to randomization more than 180 days; and vertebrobasilar artery symptoms. In these situations, patients are considered to be asymptomatic.
- Pulsation is palpable in the radial and femoral arteries, and the radial artery must meet any of the following criteria: Allen test or Barbeau test suggesting that ulnar artery collateral circulation is good, or preoperative ultrasound confirming that the radial artery and ulnar artery are well developed.
- No family planning within half one year after informed consent signed, or negative pregnancy test for women with childbearing potential.
- Patients or their guardians can understand the study purpose, voluntarily participate in the trial, sign informed consent, and complete follow-up visits.
- Vascular inclusion criteria
- Lesions located in the internal carotid artery, with or without involvement of the adjacent common carotid artery (CCA).
- For symptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 70% or more on computed tomographic angiography (CTA) or magnetic resonance angiography (MRA); 50% or more on digital subtraction angiography (DSA) according to NASCET standard.
- For asymptomatic patients, at least one of the following conditions should be met: stenosis of 70% or more on ultrasonography; 80% or more on CTA or MRA; 60% or more on DSA according to NASCET standard.
- When bilateral carotid stenosis presented, only unilateral carotid artery can be treated. The other carotid artery, as a non-study artery, should be dealt with 30 days before randomization or 30 days after treatment.
- According to clinician experience, the operation access would be reasonable and the surgical instruments could be successfully delivered to the lesion site.
Exclusion
- General exclusion criteria
- Progressive stroke.
- Allergic to drugs associated with carotid artery stenting, such as lidocaine, aspirin, clopidogrel, etc.
- Allergic to contrast media or interventional device.
- Any active hemorrhage, severe anemia, coagulation disorders, or unnecessary blood transfusion treatment. Meet at least one of the following laboratory tests: hemoglobin \< 10g/dL, or platelet count \< 100000 /μ L, or unadjusted INR \>1.5, or PT beyond upper limit of normal for 1 minute, or heparin-induced thrombocytopenia.
- Previous ipsilateral large cerebral infarction stroke with sequelae, which can affect the judgment of the study end point.
- Severe cognitive disorder, unable to cooperate with treatment or postoperative evaluation.
- Spontaneous intracranial hemorrhage occurred 12 months prior to informed consent written. Ischemic stroke hemorrhage transformation occurred 3 months prior to informed consent signed.
- A new-onset stroke occurred 7 days prior to informed consent signed, which has a high hemorrhagic transformation risk after preoperative imaging evaluation.
- Any condition that could interfere with digital subtraction angiography (DSA) or make percutaneous arterial access unsafe.
- Neurological disorders occurred 2 years prior to informed consent signed, which has transient or fixed neurological deficits, cannot be distinguished from TIA or stroke.
- Participating in other clinical trials, in the research phase or follow-up phase.
- Unable to understand or sign the informed consent.
- Myocardial infarction within 30 days.
- High surgical risk, intolerance to interventional surgery, e.g., coronary artery stenosis ≥70% without or unable to revascularization; ejection fraction \< 30% or NYHA classification ≥class III; stable angina pectoris (static angina pectoris with ECG changes); organ transplantation (such as heart, lung, liver and kidney) planned or under evaluation; malignant tumour or respiratory insufficiency making life expectancy less than 5 years or FEV1\< 30%(prediction); dialysis-dependent renal failure; poorly controlled diabetes mellitus(fast serum glucose \>400 mg/dl and urine ketone \> +2).
- Diseases or anatomical features that would prevent from carotid artery stenting, such as pathway problems caused by cervical radiation therapy, and cervical space occupying lesion compressing carotid artery
- Vascular exclusion criteria
- Severe vascular tortuosity or dissection that influence catheters delivering
- Stenting, balloon dilation or coiling were performed in ipsilateral vessels in the past.
- Extensive or diffuse atherosclerotic disease involving the aortic arch and the proximal common carotid artery, which would influence catheters delivering
- Besides the target vessel, there are also ipsilateral intracranial or extracranial arteries stenosis larger than the target lesion, aneurysms with the longest diameter ≥5 mm, cerebrovascular AVM(arteriovenous malformation), or other cerebrovascular disease with abnormal cerebral angiography.
- Ipsilateral carotid artery chronic occlusions.
- Plan to perform endovascular tretment of other arteries at the same time, including vertebral arteries.
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 3 2024
Estimated Enrollment :
2688 Patients enrolled
Trial Details
Trial ID
NCT05416853
Start Date
July 4 2022
End Date
September 3 2024
Last Update
September 1 2022
Active Locations (1)
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1
University of Science and Technology of China
Hefei, Anhui, China, 210000