Radial Versus Femoral Access For Carotid Artery Stenting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Carotid Artery Disease

Treatment

Carotid Artery Stenting (CAS)

Clinical Study ID

NCT05416853

2022-ky123

Ages > 18
All Genders

Study 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 of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) .

Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study.

Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach.

Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%.

Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1.The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure. 2. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 3. The incidence of death within 48 hours / 30 days post-procedure. 4. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 5. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 6. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of cerebral angiography. 2. Successful rate of CAS. 3. Degree of patient-reported comfort. 4. Operation time. 5. NIHSS score changes within 5-7 days post-procedure. 6. mRS score score within 30 days post-procedure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.

Eligibility Criteria

Inclusion

Inclusion Criteria:

General inclusion criteria

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 arterywithin 180 days before randomization.
Asymptomatic stenosis: The results of medical history, physical examination andneurological examination do not suggest ischemic symptoms in the target carotidartery. If artery stenosis degree reache the standard, but there are any one ormore of the following symptoms including: non-carotid artery symptoms;contralateral carotid artery symptoms; time from symptom to randomization morethan 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 arterymust meet any of the following criteria: Allen test or Barbeau test suggestingthat ulnar artery collateral circulation is good, or preoperative ultrasoundconfirming that the radial artery and ulnar artery are well developed.
No family planning within half one year after informed consent signed, ornegative pregnancy test for women with childbearing potential.
Patients or their guardians can understand the study purpose, voluntarilyparticipate 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 ofthe adjacent common carotid artery (CCA).
For symptomatic patients, at least one of the following conditions should bemet: stenosis of 70% or more on ultrasonography; 70% or more on computedtomographic angiography (CTA) or magnetic resonance angiography (MRA); 50% ormore on digital subtraction angiography (DSA) according to NASCET standard.
For asymptomatic patients, at least one of the following conditions should bemet: 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 canbe treated. The other carotid artery, as a non-study artery, should be dealtwith 30 days before randomization or 30 days after treatment.
According to clinician experience, the operation access would be reasonable andthe surgical instruments could be successfully delivered to the lesion site.

Exclusion

Exclusion Criteria:

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 unnecessaryblood transfusion treatment. Meet at least one of the following laboratorytests: 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-inducedthrombocytopenia.
Previous ipsilateral large cerebral infarction stroke with sequelae, which canaffect the judgment of the study end point.
Severe cognitive disorder, unable to cooperate with treatment or postoperativeevaluation.
Spontaneous intracranial hemorrhage occurred 12 months prior to informedconsent written. Ischemic stroke hemorrhage transformation occurred 3 monthsprior to informed consent signed.
A new-onset stroke occurred 7 days prior to informed consent signed, which hasa 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, whichhas transient or fixed neurological deficits, cannot be distinguished from TIAor stroke.
Participating in other clinical trials, in the research phase or follow-upphase.
Unable to understand or sign the informed consent.
Myocardial infarction within 30 days.
High surgical risk, intolerance to interventional surgery, e.g., coronaryartery stenosis ≥70% without or unable to revascularization; ejection fraction < 30% or NYHA classification ≥class III; stable angina pectoris (static anginapectoris with ECG changes); organ transplantation (such as heart, lung, liverand kidney) planned or under evaluation; malignant tumour or respiratoryinsufficiency making life expectancy less than 5 years or FEV1< 30%(prediction); dialysis-dependent renal failure; poorly controlled diabetesmellitus(fast serum glucose >400 mg/dl and urine ketone > +2).
Diseases or anatomical features that would prevent from carotid arterystenting, such as pathway problems caused by cervical radiation therapy, andcervical 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 inthe past.
Extensive or diffuse atherosclerotic disease involving the aortic arch and theproximal common carotid artery, which would influence catheters delivering
Besides the target vessel, there are also ipsilateral intracranial orextracranial arteries stenosis larger than the target lesion, aneurysms withthe longest diameter ≥5 mm, cerebrovascular AVM(arteriovenous malformation), orother 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.

Study Design