Carotid Artery StenosisNCT06722222
Gao's Triple Eversion Carotid Endarterectomy
An observational study of Carotid Artery Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Gao's triple eversion carotid endarterectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2021to 20 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310050
Zhiwei Gao, Doctor, 17357161850 ext. 86, 2317157@zju.edu.cn
About this study
Official title: A New Surgical Method for Treating Tandem Carotid Lesions: Gao's Triple Eversion Carotid Endarterectomy
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.
Read the 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.
- Conditions
- Carotid Artery Stenosis
- Being tested
- Gao's triple eversion carotid endarterectomy
- Keywords
- carotid artery stenosis, tandem carotid lesion
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gao's triple eversion carotid endarterectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Gao's triple eversion carotid endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Until the end of the study, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start17 Sep 2021
- Primary completion20 Sep 2031 (estimated)
- Study completion20 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiwei Gao, Dr., Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722222
- Sponsor's protocol ID
- 2024-1043
- Status last verified
- Nov 2024
- First submitted
- 2 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators are preparing their submission and they will share it in the receiving magazine.
Publications
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.
PubMed 24495326Davidovic 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.
PubMed 32114754Marko 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.
PubMed 33947770Goyal 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.
PubMed 26898852Assis 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.
PubMed 29021311Anadani 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.
PubMed 31577899DeCarlo 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.
PubMed 33545307Rouleau 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.
PubMed 10319972CRAWFORD 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.
PubMed 13675020
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Surgical Method for Treating Tandem Carotid Lesions: Gao's Triple Eversion Carotid Endarterectomy
- ClinicalTrials.gov ID
- NCT06722222
- Acronym / sponsor ID
- 2024-1043
- Conditions
- Carotid Artery Stenosis
- Keywords
- carotid artery stenosis, tandem carotid lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 20 Sep 2031 (estimated)
- Study completion
- 20 Sep 2031 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tandem carotid lesions | – | Procedure: Gao's triple eversion carotid endarterectomyExtracranial 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gao's triple eversion carotid endarterectomyThe 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. | Procedure or surgery | tandem carotid lesions |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 24495326Georg 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.
- Background: PubMed 32114754Davidovic 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.
- Background: PubMed 33947770Marko 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.
- Background: PubMed 26898852Goyal 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.
- Background: PubMed 29021311Assis 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.
- Background: PubMed 31577899Anadani 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.
- Background: PubMed 33545307DeCarlo 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.
- Background: PubMed 10319972Rouleau 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.
- Background: PubMed 13675020CRAWFORD 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.
- Individual participant dataSharing planned: Yes. The investigators are preparing their submission and they will share it in the receiving magazine.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhiwei Gao, Dr. study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jinren Zhou, Dr. (15995090018 ext. 86, 2324050@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Until the end of the study, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722222, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.