Status:
RECRUITING
Brachial Versus Femoral Access for Carotid Artery Stenting
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Carotid Artery Stenosis Without Infarction (Disorder)
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 cer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT06557135
Start Date
September 27 2024
End Date
December 31 2026
Last Update
July 18 2025
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000