Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06557135

Brachial Versus Femoral Access for Carotid Artery Stenting

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-07-18

226

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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;

CONDITIONS

Official Title

Brachial Versus Femoral Access for Carotid Artery Stenting

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 anemia, or coagulation disorder (e.g., hemoglobin < 10g/dL, platelet count < 100,000 /µL, unadjusted INR >1.5, or PT exceeding normal by 1 minute, or heparin-induced thrombocytopenia)
  • A large-area cerebral infarction stroke on the same side with sequelae affecting study endpoint judgment
  • History of cerebral hemorrhage in the past six months
  • Any condition interfering with digital subtraction angiography or unsafe arterial access
  • Participation in other clinical trials during research or follow-up stages
  • Contraindications to cerebral angiography such as allergy to iodine contrast or renal insufficiency
  • Unable to understand or sign informed consent
  • Severe functional damage to important organs with high surgical risk
  • Baseline modified Rankin scale ≥ 2
  • Expected survival less than 6 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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Research Team

K

kai Qiu, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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