Gao's Triple Eversion Carotid Endarterectomy

Recruiting

• Conditions: Carotid Artery Stenosis

• Registration Number: NCT06722222
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Carotid endarterectomy (CEA), an important surgical approach for managing carotid plaque, has evolved over more than 70 years but still cannot be applied to all tandem carotid lesions (TCLs) because of the wide range of these lesions. Herein, the investigators introduce an innovative CEA, Gao's triple eversion CEA (GTE-CEA), for the treatment of TCLs.

Detailed Description

The investigators retrospectively reviewed the charts of patients who underwent GTE-CEA performed by the same group of vascular surgeons since 17 September, 2021. Patients who did not meet the diagnostic criteria for carotid artery stenosis (CAS); those with asymptomatic CAS \< 50%, preoperatively confirmed by digital subtraction angiography (DSA) or computed tomography angiography (CTA); and those with stenosis at the opening of the common carotid artery (CCA) were excluded from our study.

Study Timeline

• Study Start: 2021-09-17
• Status Verified: 2024-11
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2031-09-20
• Study Completion: 2031-09-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Meet the diagnostic criteria for TCL stenosis.
• Above 70% asymptomatic CCA and ICA stenosis or > 50% symptomatic CAS confirmed by DSA or CTA before surgery

Exclusion Criteria

• Did not meet the diagnostic criteria for CAS
• Asymptomatic CAS < 50% (as confirmed by DSA or CTA before surgery)
• With stenosis at the opening of the CCA.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Until the end of the study, an average of 3 years	Digital subtraction angiography (DSA) or computed tomography angiography showed carotid artery recanalization and no risk complications such as stroke

Trial Locations

Locations (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China