Effectiveness of Surgical and Diagnostic Methods in Cerebral Vascular Occlusive Disease

NCT07396025 | Enrolling By Invitation

• 2 other identifiers: 26100905AP26100905
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Occlusion

Keywords

stroke, carotid artery occlusion, cerebral bypass, STA-MCA bypass, atherosclerosis, CT and MRI perfusion, cerebral angiography; stroke; carotid artery occlusion; cerebral bypass; STA-MCA bypass; atherosclerosis; CT and MRI perfusion; cerebral angiograph

Outcome Measures

Primary Outcomes (3)

• STA-MCA bypass patency

  Patency of the extracranial-intracranial bypass will be assessed using CTA of the head and neck and classified as patent or occluded.

  From enrollment to the further follow-up of 6, 12, and 24 months.

• Donor superficial temporal artery caliber

  Diameter of the donor superficial temporal artery branch at the anastomosis site measured using CTA imaging.

  6, 12, and 24 months after surgery

• Cerebral perfusion changes

  Quantitative cerebral perfusion parameters assessed using MR perfusion imaging with 3D segmentation and compared with preoperative baseline values.

  6, 12, and 24 months after surgery

Secondary Outcomes (1)

• Global cognitive function

  Preoperatively; at discharge; 6, 12, and 24 months after surgery

Other Outcomes (3)

• Verbal memory performance

  Preoperatively; at discharge; 6, 12, and 24 months after surgery

• Visuospatial and executive function

  Preoperatively; at discharge; 6, 12, and 24 months after surgery

• Cognitive control and processing speed

  Preoperatively; at discharge; 6, 12, and 24 months after surgery

Study Arms (1)

patients with chronic occlusive internal carotid artery cerebrovascular disease

OTHER

Procedure: Revascularization/Conservative management

Interventions

Revascularization/Conservative management PROCEDURE

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.

patients with chronic occlusive internal carotid artery cerebrovascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Patients aged under 18
• 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
• Severe systemic comorbidities, life expectancy \<2 years, or a modified Rankin Scale (mRS) score \>3.
• Pregnancy.
• Contraindications to MRI, CTA, DSA, iodinated contrast agents, or antiplatelet therapy required in the perioperative period.
• Participation in another interventional or experimental trial within the previous 12 months, including studies involving ionizing radiation

Sponsors & Collaborators

• National Centre for Neurosurgery, Republic of Kazakhstan: lead

Study Sites (1)

National Centre for Neurosurgery

Astana, 01000, Kazakhstan

Location

MeSH Terms

Conditions

Stroke; Atherosclerosis

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 9, 2026
• Study Start: July 9, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

KA (1)