NCT07288164

Brief Summary

Atherosclerotic carotid artery disease is responsible for approximately 20% of strokes worldwide, and its treatment options include medical therapy, surgery, and stenting.Surgical management is prioritized over medical and stent based approaches and can be performed using either the conventional methed closed primarily or with a patch or the eversion technique.The aim of this study was to compare the intraoperative and early postoperative outcomes of the eversion technique and the conventional method with primary closure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

January 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of participants with stroke and death

    All strokes and/or deaths occurring within 30 days after surgery

    30 days

  • Number of participants with symptoms of occlusion

    Early carotid restenosis or occlusion within 30 days after surgery

    Postoperative 30 days

Study Arms (2)

Conventional endarterectomy

Who were performed conventional,primarily endarterectomy patients are included this group

Procedure: Carotid endarterectomy, conventional

Eversion

Who were performed eversion endarterectomy patients are included this group

Procedure: Carotid endarterectomy, eversion

Interventions

In this study, patients were divided into two groups according to whether they underwent conventional or eversion endarterectomy. Although the eversion technique is the oldest method, the conventional approach is still widely performed due to its ease of application, despite not being recommended in current guidelines. Therefore, our aim is to contribute to the literature by comparing these two methods.The eversion method is performed by transecting the internal carotid artery (ICA) from the common carotid artery (CCA). The arteriotomy is then closed in an end to side fashion.

Eversion

In this study, patients were divided into two groups according to whether they underwent conventional or eversion endarterectomy. Although the eversion technique is the oldest method, the conventional approach is still widely performed due to its ease of application, despite not being recommended in current guidelines. Therefore, our aim is to contribute to the literature by comparing these two methods. The conventional method is performed with a longitudinal incision extending from the common carotid artery (CCA) to the internal carotid artery (ICA) up to the end of the plaque. The arteriotomy is then closed either primarily or with the use of a patch. In our study, we performed only the primary closure method..

Conventional endarterectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Carotid endarterectomy was performed in patients with 50-99% stenosis who had experienced stroke or transient ischemic attack (TIA) within the last six months, as well as in asymptomatic patients with 70-99% stenosis. These patients were divided into two groups according to the surgical technique applied conventional or eversion carotid endarterectomy and intraoperative and early postoperative outcomes were compared between the groups.

You may qualify if:

  • Patients undergoing isolated carotid endarterectomy, either emergently or electively

You may not qualify if:

  • Patients younger than 18 years of age
  • Patients scheduled for concomitant cardiac surgery
  • Reoperations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (11)

  • Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.

    PMID: 10471419BACKGROUND
  • Wu S, Wang H, Guo J, Zhang F, Pan D, Ning Y, Gu Y, Guo L. Comparative on the effectiveness and safety of different carotid endarterectomy techniques: a single-center Retrospective Study. J Cardiothorac Surg. 2024 Jun 20;19(1):338. doi: 10.1186/s13019-024-02838-0.

    PMID: 38902703BACKGROUND
  • Schneider JR, Helenowski IB, Jackson CR, Verta MJ, Zamor KC, Patel NH, Kim S, Hoel AW; Society for Vascular Surgery Vascular Quality Initiative and the Mid-America Vascular Study Group. A comparison of results with eversion versus conventional carotid endarterectomy from the Vascular Quality Initiative and the Mid-America Vascular Study Group. J Vasc Surg. 2015 May;61(5):1216-22. doi: 10.1016/j.jvs.2015.01.049.

    PMID: 25925539BACKGROUND
  • Jonsson M, Lindstrom D, Wanhainen A, Djavani Gidlund K, Gillgren P. Near Infrared Spectroscopy as a Predictor for Shunt Requirement During Carotid Endarterectomy. Eur J Vasc Endovasc Surg. 2017 Jun;53(6):783-791. doi: 10.1016/j.ejvs.2017.02.033. Epub 2017 Apr 19.

    PMID: 28431821BACKGROUND
  • Ben Ahmed S, Daniel G, Benezit M, Ribal JP, Rosset E. Eversion carotid endarterectomy without shunt: concerning 1385 consecutive cases. J Cardiovasc Surg (Torino). 2017 Aug;58(4):543-550. doi: 10.23736/S0021-9509.16.08495-0. Epub 2015 Feb 12.

    PMID: 25673097BACKGROUND
  • Deser SB, Demirag MK, Kolbakir F. Does surgical technique influence the postoperative hemodynamic disturbances and neurological outcomes in carotid endarterectomy? Acta Chir Belg. 2019 Apr;119(2):78-82. doi: 10.1080/00015458.2018.1459364. Epub 2018 Apr 27.

    PMID: 29701500BACKGROUND
  • Yuruk MA, Ozdemir AC. Eversion versus conventional carotid endarterectomy: A retrospective cohort study. Medicine (Baltimore). 2025 Aug 15;104(33):e43908. doi: 10.1097/MD.0000000000043908.

    PMID: 40826780BACKGROUND
  • Yasa H, Akyuz M, Yakut N, Aslan O, Akyuz D, Ozcem B, Tulukoglu E, Gurbuz A. Comparison of two surgical techniques for carotid endarterectomy: conventional and eversion. Neurochirurgie. 2014 Feb-Apr;60(1-2):33-7. doi: 10.1016/j.neuchi.2013.12.003. Epub 2014 Mar 24.

    PMID: 24673880BACKGROUND
  • Lee JH, Suh BY. Comparative results of conventional and eversion carotid endarterectomy. Ann Surg Treat Res. 2014 Oct;87(4):192-6. doi: 10.4174/astr.2014.87.4.192. Epub 2014 Sep 25.

    PMID: 25317414BACKGROUND
  • Kakisis JD, Antonopoulos CN, Moulakakis KG, Schneider F, Geroulakos G, Ricco JB. Protamine Reduces Bleeding Complications without Increasing the Risk of Stroke after Carotid Endarterectomy: A Meta-analysis. Eur J Vasc Endovasc Surg. 2016 Sep;52(3):296-307. doi: 10.1016/j.ejvs.2016.05.033. Epub 2016 Jul 4.

    PMID: 27389942BACKGROUND
  • Gahremanpour A, Perin EC, Silva G. Carotid artery stenting versus endarterectomy: a systematic review. Tex Heart Inst J. 2012;39(4):474-87.

    PMID: 22949763BACKGROUND

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Interventions

Endarterectomy, CarotidCongresses as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeOrganizationsHealth Care Economics and Organizations

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Literally: Doctor Teaching Member

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

May 15, 2025

Primary Completion

August 30, 2025

Study Completion

September 30, 2025

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations