Carotid Endarterectomy and Stenting Timing:The CEST Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To compare the safety and efficacy of carotid revascularization performed within 48 hours versus after 14 days in patients with symptomatic carotid stenosis accompanied with MRI-confirmed acute infarction (high signal on diffusion-weighted imaging accompanied by low apparent diffusion coefficient signal) in the responsible vascular territory.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years;

• Diagnosed with symptomatic carotid stenosis, defined as the occurrence of sudden-onset neurological symptoms within the territory of the responsible artery within 180 days before randomization (e.g., contralateral hemiparesis, slurred speech/difficulty in expression, ipsilateral monocular vision loss, etc.);

• Stenosis located in the extracranial segment of the internal carotid artery (with or without involvement of the adjacent common carotid artery);

• Degree of stenosis in the responsible carotid artery confirmed to be ≥50% and ≤99% by CTA/MRA/DSA, based on NASCET criteria;

• Brain MRI within 72 hours before randomization indicating an acute infarction in the responsible vascular territory, characterized by high signal on DWI and low signal on ADC;

• Modified Rankin Scale (mRS) score \<3;

• Written informed consent obtained from the patient or their legal representative.

Locations
Other Locations
China
Xuanwu Hospital, Capital Medical University.
RECRUITING
Beijing
Contact Information
Primary
Yan Prof. Ma, MD
xrqssq@126.com
+86 15001376121
Time Frame
Start Date: 2025-03-07
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 268
Treatments
Experimental: CEA/CAS within 48 hours after randomization
All the participants in this group will be performed with CEA/CAS plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day before surgery. If CEA was assigned, mono anti-platelet therapy will be performed thereafter. If CAS was assigned, dual-antiplatelet will be performed for 3 months after surgery followed by mono anti-platelet therapy thereafter. CAS or CAS will be performed within 48h after randomization.
Other: CEA/CAS after 14 days of randomization
All the participants in this group will be performed with CEA/CAS plus best medical treatment including Aspirin 100mg per day + Clopidogrel 75mg per day or Ticagrelor 90mg twice per day before surgery. If CEA was assigned, mono anti-platelet therapy will be performed thereafter. If CAS was assigned, dual-antiplatelet will be performed for 3 months after surgery followed by mono anti-platelet therapy thereafter. CEA or CAS will be performed 14 days after randomization.
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov