NCT06294496

Brief Summary

Ischemic stroke affects 2.5 to 3 million people annually in China, ranking as the leading cause of death and disability. Cervical artery stenosis is a significant contributor to this problem, with about 50% of patients experiencing cognitive impairment due to reduced cerebral blood flow. Two main surgical approaches, carotid endarterectomy (CEA) and carotid artery stenting (CAS), are used to treat severe cervical artery stenosis, but their effects on various factors remain unclear. This project collects multimodal imaging data, including CT perfusion and angiography, to create 3D models of cervical artery stenosis. Computational fluid dynamics and AI analysis are used to assess hemodynamics. By monitoring blood flow, oxygen levels, and evaluating postoperative outcomes, the goal is to tailor surgical approaches for better patient outcomes and improved quality of life.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.6 years

First QC Date

September 16, 2023

Last Update Submit

March 4, 2024

Conditions

Carotid Stenosis

Keywords

Carotid StenosisMultimodal ImagingComputational Fluid Dynamics

Outcome Measures

Primary Outcomes (1)

  • Perioperative cardio-cerebrovascular adverse events

    Specific adverse events related to the cardiovascular and cerebrovascular systems that may occur during the perioperative period , encompassing the time before, during, and after a CEA. These events include myocardial infarction (heart attack), cerebral hyperperfusion injury, stroke, arrhythmias (abnormal heart rhythms), and death.

    2 weeks after surgery

Secondary Outcomes (2)

  • Compute fluid dynamics parameters

    1 day before the surgery, 3 days after the surgery

  • Clinical outcome

    6 months after surgery

Study Arms (2)

CEA group

The patient with carotid stenosis underwent CEA surgery.

Procedure: CEA/CAS

CAS group

The patient with carotid stenosis underwent CAS treatment.

Procedure: CEA/CAS

Interventions

CEA/CASPROCEDURE

carotid endarterectomy (CEA) and carotid artery stenting (CAS)

CAS groupCEA group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged between 18 and 80 years old

You may qualify if:

  • \) Clinical diagnosis of carotid stenosis.

You may not qualify if:

  • Vascular stenosis with vascular malformations.
  • Aneurysm.
  • Severe heart, liver, or kidney disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

RECRUITING

Related Publications (8)

  • Pessin MS, Hinton RC, Davis KR, Duncan GW, Roberson GH, Ackerman RH, Mohr JP. Mechanisms of acute carotid stroke. Ann Neurol. 1979 Sep;6(3):245-52. doi: 10.1002/ana.410060311.

    PMID: 534423BACKGROUND

  • Wu S, Wu B, Liu M, Chen Z, Wang W, Anderson CS, Sandercock P, Wang Y, Huang Y, Cui L, Pu C, Jia J, Zhang T, Liu X, Zhang S, Xie P, Fan D, Ji X, Wong KL, Wang L; China Stroke Study Collaboration. Stroke in China: advances and challenges in epidemiology, prevention, and management. Lancet Neurol. 2019 Apr;18(4):394-405. doi: 10.1016/S1474-4422(18)30500-3.

    PMID: 30878104BACKGROUND

  • Pandian JD, Gall SL, Kate MP, Silva GS, Akinyemi RO, Ovbiagele BI, Lavados PM, Gandhi DBC, Thrift AG. Prevention of stroke: a global perspective. Lancet. 2018 Oct 6;392(10154):1269-1278. doi: 10.1016/S0140-6736(18)31269-8.

    PMID: 30319114BACKGROUND

  • Lanzino G, Tallarita T, Rabinstein AA. Internal carotid artery stenosis: natural history and management. Semin Neurol. 2010 Nov;30(5):518-27. doi: 10.1055/s-0030-1268864. Epub 2011 Jan 4.

    PMID: 21207344RESULT

  • Aristova M, Vali A, Ansari SA, Shaibani A, Alden TD, Hurley MC, Jahromi BS, Potts MB, Markl M, Schnell S. Standardized Evaluation of Cerebral Arteriovenous Malformations Using Flow Distribution Network Graphs and Dual-venc 4D Flow MRI. J Magn Reson Imaging. 2019 Dec;50(6):1718-1730. doi: 10.1002/jmri.26784. Epub 2019 May 9.

    PMID: 31070849RESULT

  • Gonzales NR, Demaerschalk BM, Voeks JH, Tom M, Howard G, Sheffet AJ, Garcia L, Clair DG, Barr J, Orlow S, Brott TG; CREST Investigators. Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial. Stroke. 2014 Nov;45(11):3320-4. doi: 10.1161/STROKEAHA.114.006228. Epub 2014 Sep 25.

    PMID: 25256180RESULT

  • Fukuda S, Shimogonya Y, Yonemoto N, Fukuda M, Watanabe A, Fujiwara K, Enomoto R, Hasegawa K, Yasoda A, Tsukahara T; NHO Carotid CFD Study Group. Hemodynamic Risk Factors for the Development of Carotid Stenosis in Patients with Unilateral Carotid Stenosis. World Neurosurg. 2022 Apr;160:e353-e371. doi: 10.1016/j.wneu.2022.01.019. Epub 2022 Jan 11.

    PMID: 35026460RESULT

  • Pavlin-Premrl D, Boopathy SR, Nemes A, Mohammadzadeh M, Monajemi S, Ko BS, Campbell BCV. Computational Fluid Dynamics in Intracranial Atherosclerosis - Lessons from Cardiology: A Review of CFD in Intracranial Atherosclerosis. J Stroke Cerebrovasc Dis. 2021 Oct;30(10):106009. doi: 10.1016/j.jstrokecerebrovasdis.2021.106009. Epub 2021 Jul 31.

    PMID: 34343837RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Clinical records and radiological imaging data.

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Chunling Li, MD

    Sichuan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Guo, Master

CONTACT

+86 15760551392guoleii2021@hotmail.com

Li Xiong, Master

CONTACT

028-87393332lcl1206778081@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist, Department of Neurosurgery, Sichuan Provincial People's Hospital

Study Record Dates

First Submitted

September 16, 2023

First Posted

March 5, 2024

Study Start

June 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

After the research is completed, it is possible to share the research plan and research report with other researchers.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After the completion of the research
Access Criteria
Data are available upon reasonable request (guolleii2021@hotmail.com).

Locations

CN(1)