Brachial vErsus Femoral Access for carotId Artery sTenting: a Multicenter Randomized Clinical Trial (BEFIT)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
kai Qiu, Doctor
2232723655@qq.com
+8615895907771
Time Frame
Start Date: 2024-09-27
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 226
Treatments
Experimental: the brachial group
Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the brachial artery access.
Active_comparator: the femoral group
Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the femoral artery access.
Sponsors
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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