Carotid Artery Stenosis Without Infarction (Disorder), Ischemic Stroke
Conditions
Keywords
Brachial Artery, Femoral Artery, Carotid Artery Stenting, Carotid Stenosis
Brief summary
Study purpose: A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access. Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group. Primary endpoint: surgical success rate. Secondary endpoints: 1. Operation time (time from first arterial puncture to last angiography) 2. Serious adverse events (SAE) within 90 days; 3. Access puncture complications;
Detailed description
With the improvement of treatment concepts and the continuous innovation of interventional devices/interventional technologies, neurointervention has become the preferred treatment method for many cerebrovascular diseases. Among them, the femoral artery is the most commonly used access, because the femoral artery is superficial, easy to touch, and the relatively large vessel diameter allows most neurointerventional surgeries to proceed smoothly. However, the femoral artery access also has the disadvantages of long bed rest time, exposure to private parts, and prolonged hospitalization. Thanks to the great success of radial artery access in cardiac intervention, radial artery access is increasingly being used in neurointervention. However, due to the thin radial artery, there is a significantly increased risk of complications (radial artery spasm, radial artery occlusion) during large-cavity nerve intervention, and the operation time is significantly prolonged. Therefore, the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12%. As the superior vascular trunk of the radial artery, the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention. Anatomically, the brachial artery is superficial and easy to touch in the antecubital fossa, and there are no important vessels and nerves in front of the blood vessel, and the posterior is the distal humeral platform, which is easy for brachial artery puncture and postoperative compression hemostasis. Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery. However, current studies are based on single-center small sample studies, and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery. This study intends to conduct a multicenter, prospective, and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access.
Interventions
PROCEDURECarotid Artery Stenting (CAS)
CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis \>50%; asymptomatic stenosis \>70%) * Aged 18 or above * With palpable brachial and femoral arteries * The patient or his/her agent understands the purpose and needs of this study and signs the informed consent
Exclusion criteria
* Symptomatic stenosis or occlusion of multiple vessels at the same time * Intravascular intervention for multiple vessel lesions at the same time * Ischemic stroke within the past 2 weeks * Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin \< 10g/dL, or platelet count \< 100,000 /μ L, or unadjusted INR \>1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia * A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint * A history of cerebral hemorrhage in the past six months * Any condition that may interfere with digital subtraction angiography (DSA) or cause unsafe percutaneous arterial access Participating in other clinical trials, in the research stage or follow-up stage * Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency * Unable to understand or sign the informed consent form * Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery * Baseline modified Rankin scale greater than or equal to 2 * Expected survival is less than 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful rate of CAS | 24 hours | Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis \< 30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | 24 hours | time from first arterial puncture to last angiography |
| Serious adverse events (SAE) | 90 days | SAEs related to operation and device are defined as those related to operation procedure and device determined by investigators. Includes the incidence of death, new-onset stroke, or severe haemorrhage events within 90 days post-procedure, et al. |
| Access puncture complications | 90 days | Hematoma at access puncture site, pseudoaneurysm, arteriovenous fistula, symptomatic severe stenosis/occlusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Access conversion | 24 hours | If the randomized access was not successfully completed, switched to other access |
| Degree of patient-reported comfort | 24 hours | The comfort scale adopts the simplified General Comfort Questionnaire (GCQ）developed by nursing expert Kolcaba. The scale is scored by level 1 to 4 Likert scale, with a score range of 28-112 points. The lowest score is 28 points and the highest score is 112 points. The higher the score, the higher the comfort. A total score of \< 60 is low comfort, a total score of 60-90 is moderate comfort, and a total score of \> 90 is high comfort. |
| X-ray exposure | 24 hours | X-ray exposure is defined as the duration and equivalent of X-ray exposure recorded by the DSA machine during operation. |
Countries
China
Contacts
Primary Contactkai Qiu, Doctor
Outcome results
None listed