About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Extracranial tandem carotid lesions (TCLs) refer to two or more severe stenoses/occlusions in two or more locations in the carotid artery. TCLs are indicated for surgical intervention but are difficult to resolve by conventional carotid endarterectomy (CEA). The incidence of stenosis in the common carotid artery (CCA) combined with that in the internal carotid artery (ICA) reportedly accounts for approximately 5% of all CAS cases.
Trial design
Other
Cross-sectional
Treatments tested in this trial
Gao's triple eversion carotid endarterectomy
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Digital subtraction angiography (DSA) or computed tomography angiography showed carotid artery recanalization and no risk complications such as stroke
Sponsors and contacts
Click on the lead sponsor to view all of their trials.