Health TrialsbyHealthPanel

Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis

ConditionsIntracranial AtherosclerosisOptical Coherence TomographyPlaque, AtheroscleroticArtery StenosisIschemic Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
Sponsorjiaoliqun

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Arteriovenous Malformation

Aneurysm

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Optical Coherence Tomography

    Diagnostic test

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

  • Percutaneous transluminal angioplasty and stenting

    Procedure/Surgery

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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Optical Coherence Tomography (OCT)2 interventions
Group B: Non-Optical Coherence Tomography (N-OCT)1 intervention

Trial outcomes

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.

Time frame
30 days after enrollment

Secondary outcomes

1

Death or stroke

(long term; more than three months)

Time frame
1 year after enrollment
2

Ipsilateral stroke

(same territory as the index stenosis)

Time frame
1 year after enrollment
3

Type of recurrent event

(TIA, ischaemic stroke, haemorrhagic stroke)

Time frame
1 year after enrollment
4

Death

(long term; more than three months)

Time frame
1 year after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

jiaoliqun

Lead sponsor

Xuanwu Hospital, Beijing

Sponsor institution

Source ClinicalTrials.gov
Apply now