ClinicalTrials.gg
RecruitingNCT03295773Updated Feb 24, 2026

Morphologic Evolution and Remodeling of Intracranial Atherosclerosis: A Longitudinal Study by 3D-rotational Angiography

An observational study in Ischemic Stroke and Atheroscleroses, Cerebral, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-24.

Sponsored by Chinese University of Hong Kong · Observational

From the registry’s dates

  • Started Aug 2016; still recruiting 10 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
140
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Ischemic Stroke by Chinese University of Hong Kong — 7 open to participants now, 7 under way, none of them phase 3. Ischemic Stroke · Chinese University of Hong Kong.

Planned enrollment
6th of 10
140 · median 224
Started
2016
the only one that year
Observational
10 of 13
5 open now
Registered
2nd of 13
by date

Among the 13 studies in Ischemic Stroke by Chinese University of Hong Kong, this one is the 6th largest by planned enrollment of the 10 observational ones that give a count, is the only one that started in 2016, is one of 10 observational ones, and was the 2nd registered.

Ischemic Stroke

2,617 studies on the registry are indexed under Ischemic Stroke; 976 are open to participants now.

Browse Ischemic Stroke studies →

Open to participants now

7 of the 13 studies in Ischemic Stroke by Chinese University of Hong Kong are open now, in 2 countries. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 7 open studies →

Where they have run

Who these studies take

Of the 661 Ischemic Stroke studies recruiting now, 396 (60%) set no upper age limit and 62 (9%) stop at 75 or younger; 26 take children under 18; 42 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Ischemic Stroke by Chinese University of Hong Kong, or all of them as a file.
02

Study summary

This study is to elucidate the morphologic evolution and remodeling of ICAD under stringent control of cardiovascular risk factors.

Read the detailed description

The investigator has conducted extensive research on ICAD by transcranial Doppler ultrasound, CT angiography and perfusion studies, magnetic resonance imaging (MRI) and digital subtraction angiography (DSA) respectively. Currently, the investigator applied 3-dimensional rotational angiogram (3DRA), a selective intra-arterial catheter-based imaging technique that had a superior spatial resolution compared with CT, MRI or DSA in depicting minute (\<3mm) angio-architecture. Through 3DRA, the investigator could appreciate the ICAD patho-anatomy from a near-infinite number of planes, analyzing the stroke mechanisms and morphological changes with much improved precision. A neuro-radiologist and a stroke neurologist blind to time sequence will measure the geometric parameters and the luminal narrowing by WASID method.

03

Conditions studied

  • Ischemic Stroke
  • Atheroscleroses, Cerebral

Keywords

  • Ischemic Stroke
  • 3D-rotational angiography
  • Morphology
  • Atherosclerosis
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who have acute cerebral ischemic symptoms attributed to a high-grade (≥60%) stenosis at a middle cerebral artery or intracranial segment of an internal carotid artery (ICA) would be reviewed by neurologists. If their stroke etiology and relevance to ICAD based on clinical syndrome, vascular imaging features and concurrent cardiovascular risks are eligible, they would be invited to join the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is 30 to 85 years of age, inclusive.
  2. Patients who have an acute infarct in diffusion-weighted MRI compatible with artery-to-artery thrombo-embolism and a relevant intracranial atherosclerotic stenosis ≥60%.
  3. Patient who has no for the proposed imaging tests.
  4. Patient understands the purpose and requirements of the study, and has provided an .

Exclusion criteria

Exclusion Criteria:

Patient with any of the following conditions would be excluded:

  1. Stroke etiology uncertain or unrelated to intracranial atherosclerosis, such as cardioembolism, Moyamoya disease, small vessel disease or primary angiitis of CNS.
  2. A tandem stenosis >50% at extra-cranial internal carotid artery.
  3. Bleeding propensity: active peptic ulcer disease, major systemic hemorrhage within 30 days, thrombocytopenia ( \<100 x 109/L), coagulopathy ( >1.5).
  4. A medical condition that would not allow the patient to adhere to the protocol or complete the study.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No

Groups and cohorts

  • Symptomatic stroke patient

    Patients who are found signal void in a relevant intracranial internal carotid artery or middle cerebral artery (stenosis \>60%) will proceed to a 3-Dimensional rotational angiography (3DRA) at baseline and in 12 months. All recruited patients will receive dual antiplatelet agents for 4 weeks, followed by aspirin alone. The investigator or neurologists shall regularly review the patients and treat the conventional cardiovascular risk factors based on four pre-specified goals, for example, LDL \<1.8, HbA1c \<6.0, blood pressure \<140/90 and no smoking. The morphologic changes of the cerebral plaques with the intensity of the risk factor control in pre and post will be correlated.

    Diagnostic Test: 3DRA

Interventions

  • Diagnostic test3DRA
06

What researchers measure

Primary outcomes

  1. Morphologic Evolution and Remodeling of Intracranial Atherosclerosis

    The 3DRA images (the disparity in morphological attributes, including surface outline, angulations, plaque volume and distribution) of the patients in pre and post 12 month follow-up would be compared.

    Time frame: Dec, 2019

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2016 (actual). Primary completion is estimated for Dec 2026, 124 months after the start.

Of 396 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 124 months is above that.

Counting every sponsor, half of 438 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2017
First posted
Sep 28, 2017
StartActual
Aug 22, 2016
Primary completionEst.
Dec 28, 2026
CompletionEst.
Jun 30, 2027
Last update
Feb 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03295773
Responsible party
Leung Wai Hong Thomas (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Sep 28, 2017
Start date
Aug 22, 2016
Primary completion
Dec 28, 2026 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Feb 24, 2026

Study contacts

Thomas Wai Hong LEUNG, FRCP
Contact
drtleung@cuhk.edu.hk
852-35053593
Thomas Wai Hong LEUNG, FRCP
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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