MedTrace Logo

Radial Versus Femoral Access For Carotid Artery Stenting

NCT05416853 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-02-05

No results posted yet for this study

Summary

Background: For moderate to severe carotid artery atherosclerotic stenosis, in the past decades, carotid artery stenting (CAS) has been an alternative to carotid endarterectomy (CEA) for the treatment of carotid artery stenosis. The transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for CAS. The radial artery is an ideal puncture site for cerebrovascular intervention. Studies have shown that nerve intervention through radial artery approach can complete most cerebrovascular intervention procedures, including cerebral angiography, carotid artery stent implantation, vertebral artery stent implantation, intracranial artery stent implantation, mechanical thrombectomy, aspiration, intra-arterial thrombolysis and so on. However, the current studies are based on single center small sample studies, and there has been still a lack of large sample randomized controlled experiments to verify the safety and effectiveness of CAS in transradial artery (TRA) .

Objective: To evaluate the efficacy and safety of CAS via TRA in patients with carotid artery stenosis through a multicenter, prospective and randomized study.

Study design: This study is a randomized, open label, multicenter, parallel controlled trial. A non-inferiority test is performed to compare the primary end point between the experimental group and the control group. The experimental group will undergo carotid stent implantation via radial artery approach, while the control group will use femoral artery approach.

Study population: Adult patients with symptomatic carotid-artery stenosis ≥50% or asymptomatic stenosis ≥70%.

Study outcomes: Primary end points: The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 30 days post-procedure Secondary end points:1.The incidence of death, or new-onset stroke, or myocardial infarction, or severe hemorrhage events within 48 hours post-procedure. 2. The incidence of death, new-onset stroke and myocardial infarction within 48 hours / 30 days post-procedure. 3. The incidence of death within 48 hours / 30 days post-procedure. 4. The incidence of new-onset stroke within 48 hours / 30 days post-procedure. 5. The incidence of myocardial infarction within 48 hours / 30 days post-procedure. 6. The incidence of severe hemorrhage events within 48 hours / 30 days post-procedure. Other end points: 1. Successful rate of cerebral angiography. 2. Successful rate of CAS. 3. Degree of patient-reported comfort. 4. Operation time. 5. NIHSS score changes within 5-7 days post-procedure. 6. mRS score score within 30 days post-procedure. Safety outcomes: 1.Occurrence of all adverse events. 2. AEs related to operation and device. 3. Incidence of adverse event of special interest.

Conditions

  • Ischemic Stroke
  • Carotid Stenosis
  • Cerebral Revascularization
  • Carotid Artery Diseases

Interventions

PROCEDURE

Carotid Artery Stenting (CAS)

CAS involves insertion of a catheter or tube into an artery in the groin or the radial, and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. A stent is then placed to cover the plaque and hold the artery open.

Sponsors & Collaborators

  • The First Affiliated Hospital of University of Science and Technology of China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-04
Primary Completion
2025-03-24
Completion
2026-03-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416853 on ClinicalTrials.gov