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Gao's Triple Eversion Carotid Endarterectomy

A New Surgical Method for Treating Tandem Carotid Lesions: Gao's Triple Eversion Carotid Endarterectomy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06722222
Enrollment
11
Registered
2024-12-09
Start date
2021-09-17
Completion date
2031-09-20
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosis, tandem carotid lesion

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.

Interventions

PROCEDUREGao's triple eversion carotid endarterectomy

The carotid sheath is dissected in front of the sternocleidomastoid muscle to expose sufficient lengths of the CCA, ECA, and ICA. After raising the systolic blood pressure to 180 mmHg and intravenously injecting 1 mg/kg heparin, the superior thyroid artery is lapped and severed, and the CCA is occluded proximally to the CCA plaque, based on the plaque location shown by preoperative CTA and by intraoperative arterial exploration. Subsequently, the ECA and ICA are blocked individually. The ICA is cut diagonally at the CCA fork and the ECA is transected approximately 5 mm above its beginning. The plaque is removed with tweezers after eversion of the ICA. This process is repeated for the ECA. Finally, the long segment of plaque in the CCA is stripped proximally, followed by thorough removal of the debris on the peeling surface using heparin irrigation.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactJinren Zhou, Dr.
2324050@zju.edu.cn15995090018
Backup ContactZhiwei Gao, Dr.
2317157@zju.edu.cn17357161850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026