NCT06557135 Brachial Versus Femoral Access for Carotid Artery Stenting
| NCT ID | NCT06557135 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Carotid Artery Stenosis Without Infarction (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 226 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 226 participants in total. It began in 2024-09-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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;
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
Contact & Investigator
Sheng Liu, Professor
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT06557135 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carotid Artery Stenosis Without Infarction (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06557135 currently recruiting?
Yes, NCT06557135 is actively recruiting participants. Contact the research team at 2232723655@qq.com for enrollment information.
Where is the NCT06557135 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06557135 clinical trial?
NCT06557135 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Sheng Liu, Professor at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 226 participants.