Endovascular Treatment of Cerebrovascular Diseases Guided by Optical Coherence Tomography (OCT) Technology（CVD-OCT）

NCT06986330 | Active Not Recruiting

• 1 other identifier: 20231130
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

OCT techniques have been used in the assessment of both intracranial and extracranial lesions.(1) Preprocedural evaluation: The morphologic characteristics of carotid atherosclerotic plaques can be evaluated by OCT before surgery to identify vulnerable plaques and guide interventional therapy. It has been shown that plaque image features observed by OCT and based on the "thin fibrous cap" characteristics of plaques can predict rupture and thrombotic risk of atherosclerotic plaques. Similarly, the results of studies based on OCT plaque features suggest that OCT plaque features can be used for the identification of symptomatic carotid plaques.The results of studies based on OCT plaque characteristics suggest that OCT plaque characteristics correlate with the degree of carotid stenosis and ischemic symptoms. Therefore, it is important to use OCT to assess plaque characteristics prior to cerebrovascular interventions and to identify high-risk plaques that are prone to cause ischemic events, in order to guide carotid interventions, especially for patients whose stenosis has not reached the level of intervention, but who have not yet reached the level of ischemic events, or who are at risk of ischemic events.lesions with stenosis not reaching the level of intervention but with the presence of vulnerable plaques are of great significance.(2) Evaluation of immediate post-interventional outcomes: Currently, OCT has been used to evaluate the expansion rate of the relevant stent immediately after stenting, stent adherence, protrusion of diseased tissue into the lumen of the vessel, and in-stent thrombosis.In addition, in acute occlusion recanalization of intracranial vessels, the application of OCT can identify the nature of lesions during treatment, such as clips, atherosclerotic stenosis, and other lesions, and guide the development of surgical strategies. (3) Interventional follow-up: OCT can be used in post-interventional follow-up for post-stenting endothelial repair, in-stent restenosis, de novo atherosclerosis, and thrombus formation. In summary, OCT can accurately assess the nature of cerebrovascular lesions and plaques and guide clinical interventions.For medical centers that have the conditions, it is recommended to standardize the application of OCT to guide the interventional precision treatment of ischemic cerebrovascular disease.In the future, a clinical study database of OCT in Chinese patients with ischemic cerebrovascular disease should be established to provide evidence-based medical evidence of OCT in the diagnosis and treatment

Conditions

Carotid Stenosis; Optical Coherence Tomography (OCT); Endovascular Treatment

Outcome Measures

Primary Outcomes (1)

• Main study outcomes

  Evaluation of the characteristics of lesions in various types of cerebrovascular diseases. Use of high-resolution magnetic resonance to compare changes in different sequences of patients preoperatively and postoperatively

  Before and 3 days after surgery

Study Arms (1)

oct

The diagnosis and treatment behavior of all subjects in this study followed the requirements of the current guidelines, and there were no additional interventions.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Visiting Yijishan Hospital and needing endovascular treatment for carotid artery stenosis

You may qualify if:

• Presence of cerebrovascular disease (including asymptomatic patients);
• Cerebral angiography or intervention with OCT is required in the course of clinical diagnosis and treatment;
• Informed consent signed by the patient or the patient's legally authorized representative.

You may not qualify if:

• Patients with contrast allergy or intolerance to iodine contrast;
• Patients with tortuous blood vessels who are unable to complete OCT.

Sponsors & Collaborators

• First Affiliated Hospital of Wannan Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: November 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)