Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

NCT05550077 | Recruiting

• 1 other identifier: OCT-ICAS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).

Conditions

Intracranial Atherosclerosis; Optical Coherence Tomography; Plaque, Atherosclerotic; Artery Stenosis; Ischemic Stroke

Keywords

Optical Coherence Tomography; Intravascular Imaging; Intracranial Atherosclerotic Stenosis; Percutaneous Transluminal Angioplasty and Stenting

Outcome Measures

Primary Outcomes (1)

• Safety outcomes: short-term death or stroke

  We defined 'short-term' as the periprocedural period, or mean follow-up time less than or equal to three months after enrollment. Stroke was identified in the vascular territory of the stenosed vessel, either ischaemic or haemorrhagic. We defined death or stroke as a composite of death of any cause or non-fatal stroke of any type in any territory.

  30 days after enrollment

Secondary Outcomes (6)

• Death or stroke

  1 year after enrollment

• Ipsilateral stroke

  1 year after enrollment

• Type of recurrent event

  1 year after enrollment

• Death

  1 year after enrollment

• Restenosis

  1 year after enrollment

Study Arms (2)

Optical Coherence Tomography (OCT)

OCT and other classical imaging evaluation such as Transcranial Color Doppler (TCCD) and High resolution-MRI will be performed. The tailored treatment (such as anti-thrombotic management, post-dilation, et al) will be considered when specific plaque characteristics (including but not limited to in situ thrombus formation, macrocacilfication, et al), were observed under OCT.

Diagnostic Test: Optical Coherence Tomography; Procedure: Percutaneous transluminal angioplasty and stenting

Non-Optical Coherence Tomography (N-OCT)

Classical imaging evaluation such as TCCD and High resolution-MRI will be performed, followed by standard percutaneous transluminal angioplasty and stenting.

Procedure: Percutaneous transluminal angioplasty and stenting

Interventions

Optical Coherence Tomography DIAGNOSTIC_TEST

Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography

Optical Coherence Tomography (OCT)

Percutaneous transluminal angioplasty and stenting PROCEDURE

Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.

Non-Optical Coherence Tomography (N-OCT); Optical Coherence Tomography (OCT)

Eligibility Criteria

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

Study Population

Adults (aged over 18) with symptomatic ICAS (≥ 50%) will be enrolled.

You may qualify if:

• Symptomatic ICAS. Participants with ICAS with a transient ischaemic attack (TIA) or stroke attributable to the territory of the stenotic artery were defined as symptomatic. A TIA was defined as a transient episode of neurological dysfunction (focal weakness or language disturbance, transient monocular blindness, or required assistance in walking) caused by focal brain or retinal ischaemia that lasted for at least 10 minutes but resolved within 24 hours
• Stenotic degree ≥ 50%, measured by digital subtraction angiography
• The stenosis must located in at least one major intracranial artery (internal carotid artery, vertebral artery, middle cerebral artery, or basilar artery)

You may not qualify if:

• Arteriovenous Malformation
• Aneurysm

Sponsors & Collaborators

• jiaoliqun: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100005, China

RECRUITING

Related Publications (1)

• Li T, Xu R, Ma Y, Wang T, Yang B, Jiao L. Calcification is a risk factor for intracranial in-stent restenosis: an optical coherence tomography study. J Neurointerv Surg. 2024 Aug 14;16(9):897-901. doi: 10.1136/jnis-2023-020624.

  PMID: 37536931 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Plaque, Atherosclerotic; Ischemic Stroke

Interventions

Tomography, Optical Coherence; Angioplasty; Stents

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Stroke

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Liqun Jiao, Professor

CONTACT

+8613911224991; liqunjiao@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Interventional Neuroradiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 22, 2022
• Study Start: March 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

CN (1)