Gao's Triple Eversion Carotid Endarterectomy

NCT06722222 | Recruiting

• 1 other identifier: 2024-1043
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Stenosis

Keywords

carotid artery stenosis; tandem carotid lesion

Outcome Measures

Primary Outcomes (1)

• 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

  Until the end of the study, an average of 3 years

Study Arms (1)

tandem carotid lesions

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

Procedure: Gao's triple eversion carotid endarterectomy

Interventions

Gao's triple eversion carotid endarterectomy PROCEDURE

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.

tandem carotid lesions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310050, China

RECRUITING

Related Publications (9)

• Georg Y, Psathas E, Alomran F, Gaudric J, Chiche L, Koskas F. Double eversion carotid endarterectomy of tandem carotid lesions. Ann Vasc Surg. 2014 Jul;28(5):1186-91. doi: 10.1016/j.avsg.2013.07.018. Epub 2013 Oct 27.

  PMID: 24495326 BACKGROUND

• Davidovic LB, Tomic IZ. Eversion Carotid Endarterectomy : A Short Review. J Korean Neurosurg Soc. 2020 May;63(3):373-379. doi: 10.3340/jkns.2019.0201. Epub 2020 Mar 2.

  PMID: 32114754 BACKGROUND

• Marko M, Cimflova P, Poppe AY, Kashani N, Singh N, Ospel J, Mayank A, van Adel B, McTaggart RA, Nogueira RG, Demchuk AM, Rempel JL, Joshi M, Zerna C, Menon BK, Tymianski M, Hill MD, Goyal M, Almekhlafi MA; ESCAPE-NA1 investigators. Management and outcome of patients with acute ischemic stroke and tandem carotid occlusion in the ESCAPE-NA1 trial. J Neurointerv Surg. 2022 May;14(5):neurintsurg-2021-017474. doi: 10.1136/neurintsurg-2021-017474. Epub 2021 May 4.

  PMID: 33947770 BACKGROUND

• Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.

  PMID: 26898852 BACKGROUND

• Assis Z, Menon BK, Goyal M, Demchuk AM, Shankar J, Rempel JL, Roy D, Poppe AY, Yang V, Lum C, Dowlatshahi D, Thornton J, Choe H, Burns PA, Frei DF, Baxter BW, Hill MD; ESCAPE Trialists. Acute ischemic stroke with tandem lesions: technical endovascular management and clinical outcomes from the ESCAPE trial. J Neurointerv Surg. 2018 May;10(5):429-433. doi: 10.1136/neurintsurg-2017-013316. Epub 2017 Oct 11.

  PMID: 29021311 BACKGROUND

• Anadani M, Spiotta AM, Alawieh A, Turjman F, Piotin M, Haussen DC, Nogueira RG, Papanagiotou P, Siddiqui AH, Lapergue B, Dorn F, Cognard C, Ribo M, Psychogios MN, Labeyrie MA, Mazighi M, Biondi A, Anxionnat R, Bracard S, Richard S, Gory B; TITAN (Thrombectomy In TANdem Lesions) Investigators. Emergent Carotid Stenting Plus Thrombectomy After Thrombolysis in Tandem Strokes: Analysis of the TITAN Registry. Stroke. 2019 Aug;50(8):2250-2252. doi: 10.1161/STROKEAHA.118.024733. Epub 2019 Jun 17.

  PMID: 31577899 BACKGROUND

• DeCarlo C, Tanious A, Boitano LT, Mohebali J, Stone DH, Clouse WD, Conrad MF. Simultaneous treatment of common carotid lesions increases the risk of stroke and death after carotid artery stenting. J Vasc Surg. 2021 Aug;74(2):592-598.e1. doi: 10.1016/j.jvs.2020.12.089. Epub 2021 Feb 2.

  PMID: 33545307 BACKGROUND

• Rouleau PA, Huston J 3rd, Gilbertson J, Brown RD Jr, Meyer FB, Bower TC. Carotid artery tandem lesions: frequency of angiographic detection and consequences for endarterectomy. AJNR Am J Neuroradiol. 1999 Apr;20(4):621-5.

  PMID: 10319972 BACKGROUND

• CRAWFORD ES, DEBAKEY M, FIELDS WS, MORRIS GC Jr, COOLEY DA. Surgical considerations in the treatment of cerebral arterial insufficiency; scientific exhibit. Postgrad Med. 1959 Aug;26(2):227-37. doi: 10.1080/00325481.1959.11712569. No abstract available.

  PMID: 13675020 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhiwei Gao, Dr.

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Jinren Zhou, Dr.

CONTACT

15995090018; 2324050@zju.edu.cn

Zhiwei Gao, Dr.

CONTACT

17357161850; 2317157@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: September 17, 2021
• Primary Completion (Estimated): September 20, 2031
• Study Completion (Estimated): September 20, 2031
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will become available after the submission is received by a magezine.
• Access Criteria: The data that support the findings of this study are available from Zhiwei Gao upon reasonable request.

Locations

CN (1)