Brachial Versus Femoral Access for Carotid Artery Stenting (NCT06557135) | Clinical Trial Compass
RecruitingNot Applicable
Brachial Versus Femoral Access for Carotid Artery Stenting
China226 participantsStarted 2024-09-27
Plain-language 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;
Who can participate
Age range18 Years
SexALL
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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 p…
What they're measuring
1
Successful rate of CAS
Timeframe: 24 hours
Trial details
NCT IDNCT06557135
SponsorThe First Affiliated Hospital with Nanjing Medical University