An observational study in Internal Carotid Artery Dolichoarteriopathy and Carotid Artery Tortuosity, sponsored by Kuban State Medical University. Not yet recruiting at 1 site in Russia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Kuban State Medical University · Observational
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.
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.
355 studies on the registry are indexed under Brain Ischemia; 71 are open to participants now.
This study's planned enrollment of 560 is above the median of 101 across 128 observational studies indexed under Brain Ischemia.
Browse Brain Ischemia studies →Kuban State Medical University is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
Time frame: From baseline through 24 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 24 months
Change in Anti-NR2 Antibody Level
Change from baseline in circulating anti-NR2 antibody level during prospective follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through 24 months
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Kuban State Medical University