Effectiveness of Surgical and Diagnostic Methods in Cerebral Vascular Occlusive Disease (NCT07396025) | Clinical Trial Compass
By InvitationNot Applicable
Effectiveness of Surgical and Diagnostic Methods in Cerebral Vascular Occlusive Disease
Kazakhstan60 participantsStarted 2025-07-09
Plain-language summary
This study attempts to improve surgical treatment outcomes among people with chronic carotid artery occlusive disease by conducting a comprehensive review of neuroradiological, clinical, and cognitive data. The evaluation involves an extensive angiographic analysis, including pre- and postoperative measurements of superficial temporal artery branch diameters, assessment of the Circle of Willis and collateral pathways, alongside cerebral perfusion metrics, cognitive status, and clinical outcomes. Major focus is directed towards evaluating the degree of intracranial revascularization following to extracranial-intracranial bypass by postoperative angiographic evaluations. This integrative strategy aims to refine surgical reasons, better predictions of functional and cognitive outcomes, minimize postoperative risks, and eventually improve the overall efficacy of treatment in this patient population.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients with ICA occlusion confirmed by CTA, MRA, and cerebral DSA.
✓. MRI ASL-confirmed hypoperfusion in the territory of the occluded ICA (decrease of ≥30% compared with the contralateral side)
✓. Language comprehension is preserved, with mild or no motor aphasia and no significant cognitive impairment.
✓. Patients aged from 18 to 80 years.
✓. Modified Rankin Scale (mRS) score 0-2.
✓. Informed consent is available from the patient or legal guardian.
✓. Accessible and reliable patients for follow-up
Exclusion criteria
✕. Patients with large territorial infarction or marked cerebral atrophy on MRI.
✕. No evidence of regional hypoperfusion on ASL MRI relative to the contralateral hemisphere.
✕. Patients with a non-functioning STA-MCA bypass
What they're measuring
1
STA-MCA bypass patency
Timeframe: From enrollment to the further follow-up of 6, 12, and 24 months.
2
Donor superficial temporal artery caliber
Timeframe: 6, 12, and 24 months after surgery
3
Cerebral perfusion changes
Timeframe: 6, 12, and 24 months after surgery
Trial details
NCT IDNCT07396025
SponsorNational Centre for Neurosurgery, Republic of Kazakhstan
✕. Patients with severe somatic conditions or mRS score \> 3
✕. Patients with bilateral ICA occlusion, neurovascular disease (cerebral aneurysm or arteriovenous malformation)
✕. Patients with Contraindications to MRI, CTA, or DSA
✕. Cardiac conditions associated with a high risk of cerebral embolism, including prosthetic heart valves, infective endocarditis, intracardiac thrombus, sick sinus syndrome, cardiac myxoma, or cardiomyopathy with left ventricular ejection fraction \<25% (atrial fibrillation, patent foramen ovale, and atrial septal aneurysm are not exclusion criteria).