Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
11 participants
OBSERVATIONAL
2021-09-17
2031-09-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Gao'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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gao'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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Above 70% asymptomatic CCA and ICA stenosis or \> 50% symptomatic CAS confirmed by DSA or CTA before surgery
Exclusion Criteria
* Asymptomatic CAS \< 50% (as confirmed by DSA or CTA before surgery)
* With stenosis at the opening of the CCA.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhiwei Gao, Dr.
Role: STUDY_DIRECTOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Zhiwei Gao, Doctor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-1043
Identifier Type: -
Identifier Source: org_study_id