Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).
Stroke was the second leading cause of death worldwide and the leading cause of death in China in 2017. ICAS accounted for 10% to 15% of ischemic stroke in Western countries, and as much as 46.6%in Asia in 2009.
For patients with ICAS, the risk of stroke is highly related to the histopathology of atheromatous plaques. Therefore, characterizing the morphology and composition of plaques in ICAS may help to predict the risk of stroke occurrence and allow the adoption of preventive or therapeutic management to prevent such life-threatening events. OCT, with a resolution of 10μm, may provide more reliable information in characterizing atheromatous plagues.
This study aims to get a better insight into the value of OCT in evaluating the vessel wall structure and therefore guiding the interventional therapy of ICAS. In addition, the clinical and biological information will be included to achieve correlation analysis so as to get biomarkers subject to various plaque characteristics.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Diagnostic Test | Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Death or stroke | (long term; more than three months) | 1 year after enrollment |
| Ipsilateral stroke | (same territory as the index stenosis) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adults (aged over 18) with symptomatic ICAS (≥ 50%) will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liqun Jiao, Professor | Contact | +8613911224991 | liqunjiao@sina.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100005 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37536931 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D058226 | Plaque, Atherosclerotic |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| D017130 | Angioplasty |
| D015607 | Stents |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Peripheral blood
| Percutaneous transluminal angioplasty and stenting | Procedure | Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation. |
|
| 1 year after enrollment |
| Type of recurrent event | (TIA, ischaemic stroke, haemorrhagic stroke) | 1 year after enrollment |
| Death | (long term; more than three months) | 1 year after enrollment |
| Restenosis | (≥ 50%) of the involved vessel documented by conventional cerebral angiography | 1 year after enrollment |
| Dependency | Modified Rankin Scale or equivalent | 1 year after enrollment |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020521 | Stroke |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |