Internal Carotid Artery DolichoarteriopathyDALISTANCT07882875
Clinical Significance of Internal Carotid Artery Dolichoarteriopathy
An observational study of Internal Carotid Artery Dolichoarteriopathy and Carotid Artery Tortuosity, run by Kuban State Medical University at 1 site in Russia.
Trial summary
This observational study aims to investigate the clinical significance of internal carotid artery dolichoarteriopathy, including tortuosity, kinking, and coiling, and to identify factors associated with cerebral dysfunction and adverse cerebrovascular outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Internal Carotid Artery Dolichoarteriopathy, Carotid Artery Tortuosity
- How many people
- 560 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2026to Dec 2029
- Phase
- Observational
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women aged 18-75 years with verified internal carotid artery dolichoarteriopathy, including tortuosity, kinking, and/or coiling, who are undergoing diagnostic evaluation, conservative follow-up, or surgical treatment. The prospective study population will include participants eligible for longitudinal follow-up in either an observational surgical cohort or an observational conservative cohort. Treatment strategy is determined independently by the treating physician according to routine clinical indications and is not assigned by the study protocol.
Who may be able to join
- Age 18 to 75 years, inclusive.
- Verified pathological deformation of the internal carotid artery, including tortuosity, kinking, and/or coiling, confirmed by duplex ultrasound and/or angiographic imaging.
- Ability to undergo baseline clinical and neurological assessment and longitudinal follow-up.
- Written informed consent for participation and processing of personal data. Separate optional consent may be obtained for storage of residual biospecimens and genetic testing, where applicable.
Who cannot join
- Acute ischemic or hemorrhagic stroke within 6 months before planned enrollment if the participant's condition prevents valid baseline assessment or study procedures.
- Complete occlusion of the study internal carotid artery or brachiocephalic trunk that prevents valid assessment of the pathophysiological role of arterial tortuosity.
- Hemodynamically significant atherosclerotic stenosis of the internal carotid artery greater than 50% on the side relevant to the analysis when it represents the dominant alternative cause of impaired blood flow.
- Unstable angina, NYHA class III-IV heart failure, or another decompensated cardiovascular condition that prevents safe participation.
- Myocardial infarction within the previous 3 months.
- Severe cognitive impairment or dementia preventing valid informed consent or neuropsychological assessment, unless participation is legally permitted through an authorized representative.
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- Active malignancy or systemic treatment expected to substantially affect the investigated biomarkers or prognosis.
- Decompensated respiratory, renal, or hepatic disease that may substantially affect safety or interpretation of study results.
- Psychiatric disorder or other condition preventing adequate communication or adherence to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Research Institute-Regional Clinical Hospital No. 1 Named After Prof. S.V. Ochapovsky
Krasnodar, Krasnodarskiy Kray, 350086
Iana V Kabanova
Roman A Vinogradov, Doctor of Sciences
About this study
Official title: Personalized Treatment Strategy for Internal Carotid Artery Dolichoarteriopathy Based on Objective Assessment of Cerebral Dysfunction and Outcome Prediction
This observational study aims to investigate the clinical significance of internal carotid artery dolichoarteriopathy, including tortuosity, kinking, and coiling, and to identify factors associated with cerebral dysfunction and adverse cerebrovascular outcomes. The study combines retrospective clinical data with prospective follow-up of patients with verified internal carotid artery dolichoarteriopathy. Anatomical, hemodynamic, neuroimaging, clinical, cognitive, and biomarker characteristics will be evaluated to develop and validate a multimodal approach to risk stratification. Outcomes will also be compared between patients managed surgically and conservatively according to routine clinical indications. Treatment decisions are made independently by the treating physicians and are not assigned by the study protocol.
Read the detailed description
DALISTA is a prospective-retrospective observational cohort study designed to investigate the clinical and hemodynamic significance of internal carotid artery dolichoarteriopathy. The study focuses on patients with verified tortuosity, kinking, and/or coiling of the internal carotid artery who are undergoing diagnostic evaluation, conservative follow-up, or surgical treatment in routine clinical practice.
The retrospective component is used to identify candidate clinical, anatomical, hemodynamic, and neuroimaging predictors associated with cerebral dysfunction and cerebrovascular risk. The prospective component is intended to validate these findings and assess clinical outcomes over longitudinal follow-up.
Study assessments may include vascular morphology, ultrasound and angiographic characteristics, cerebral and local hemodynamics, neuroimaging findings, neurological and cognitive status, selected circulating biomarkers, and other clinically relevant vascular risk factors. Computational modeling and statistical or machine-learning approaches may be used to integrate these variables and develop a multimodal risk-stratification model.
Patients who undergo surgical correction according to routine clinical indications will be evaluated as an observational surgical cohort, while patients receiving conservative management will form an observational conservative cohort. Assignment to surgical or conservative management is not determined by the research protocol. The investigational risk-stratification model is not used as the sole basis for clinical treatment decisions before completion of its validation.
The overall objective is to identify reproducible criteria that may help distinguish clinically significant carotid dolichoarteriopathy and support future evidence-based selection of patients who may benefit from intensified surveillance or surgical treatment.
- Keywords
- Dolichoarteriopathy, Internal Carotid Artery, Carotid Tortuosity, Kinking, Coiling, Cerebral Hemodynamics, Cerebral Perfusion, Cerebrovascular Risk, Risk Stratification, Cognitive Function, cerebral ischemia, ischemic stroke, stroke, cognitive impairment
- Medical subject headings
- Brain Ischemia, Ischemic Stroke, Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Cohort | Participants with internal carotid artery dolichoarteriopathy who undergo surgical correction according to routine clinical indications and standard clinical decision-making. Surgical treatment is not assigned by the study protocol. | |
| Conservative Cohort | Participants with internal carotid artery dolichoarteriopathy who receive conservative management according to routine clinical indications, including patients for whom surgery is not indicated, is contraindicated or deferred, or is declined by the patient. Treatment is not assigned by the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Ipsilateral Ischemic Stroke and/or Transient Ischemic Attack
Number and proportion of participants who experience at least one ipsilateral ischemic stroke and/or transient ischemic attack during prospective follow-up. Events will be evaluated using clinical and available neuroimaging data, with consideration of alternative cerebrovascular mechanisms.
Measured: From baseline through 24 months
Secondary outcomes (12)
Change in Montreal Cognitive Assessment (MoCA) Score
Change from baseline in cognitive performance measured using the Montreal Cognitive Assessment (MoCA). Higher scores indicate better cognitive performance.
Measured: Baseline through 24 months
Change in Frontal Assessment Battery (FAB) Score
Change from baseline in frontal and executive cognitive function measured using the Frontal Assessment Battery (FAB). Higher scores indicate better frontal and executive function.
Measured: Baseline through 24 months
Change in Trail Making Test (TMT) Performance
Change from baseline in Trail Making Test performance measured by completion time during prospective follow-up. Longer completion time indicates poorer test performance.
Measured: Baseline through 24 months
New or Progressive Structural Cerebral Abnormalities on MRI
Number and proportion of participants with at least one new or progressive structural cerebral abnormality on magnetic resonance imaging compared with baseline imaging, including predefined study-relevant signs of cerebral ischemic or vascular injury.
Measured: Baseline through 24 months
Change in Serum Neurofilament Light Chain Level
Change from baseline in serum neurofilament light chain (sNfL) concentration during prospective follow-up.
Measured: Baseline through 24 months
Change in Glial Fibrillary Acidic Protein Level
Change from baseline in circulating glial fibrillary acidic protein (GFAP) concentration during prospective follow-up.
Measured: Baseline through 24 months
Change in Anti-NR2 Antibody Level
Change from baseline in circulating anti-NR2 antibody level during prospective follow-up.
Measured: Baseline through 24 months
Change in Modified Rankin Scale (mRS) Score
Change from baseline in functional status measured using the modified Rankin Scale (mRS). Higher scores indicate greater disability.
Measured: Baseline through 24 months
Change in SF-36 Health-Related Quality of Life Score
Change from baseline in health-related quality of life measured using the 36-Item Short Form Health Survey (SF-36) according to the study assessment schedule.
Measured: Baseline through 24 months
Change in VascuQoL-6 Score
Change from baseline in vascular disease-related quality of life measured using the VascuQoL-6 questionnaire. Higher scores indicate better health-related quality of life.
Measured: Baseline through 24 months
Patency of the Reconstruction
Number and proportion of participants in the surgical cohort with a patent reconstructed carotid artery segment as assessed by duplex ultrasound during follow-up.
Measured: Baseline through 24 months
Vascular Events in the Surgical Cohort
Number and proportion of participants in the surgical cohort experiencing at least one predefined perioperative or late vascular event during follow-up.
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Carotid Artery DolichoarteriopathyStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuban State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Bogdan, Kuban State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882875
- Sponsor's protocol ID
- DALISTA-2026
- Acronym
- DALISTA
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned for public sharing because the study includes sensitive clinical, neuroimaging, biomarker, and genetic information. Any future access to de-identified data would require separate approval by the study investigators and, where applicable, the ethics committee and institutional data-protection procedures.