Brachial Versus Femoral Access for Carotid Artery Stenting

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different ways of accessing blood vessels for a procedure called carotid artery stenting, which is done to treat a narrowing of the carotid artery that can lead to strokes. Participants in the study will be randomly assigned to have the procedure done either through the brachial artery in the arm or the femoral artery in the leg. The main goal of the study is to see which method is more successful in achieving good results without complications.

To be eligible for the trial, participants must be at least 18 years old and have a specific type of narrowing in their carotid artery that needs treatment. They should also be able to feel their brachial and femoral arteries, and understand the study’s purpose to provide consent. However, individuals with certain health issues, recent strokes, or those who can't safely undergo the required tests or procedures will not be included. If you join the study, you can expect to be monitored for any serious side effects for 90 days after the procedure, and the total time for the operation will be recorded. This trial is not yet recruiting participants, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

• 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