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Ischemic StrokeNCT05578300

Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific

An observational study of Ischemic Stroke and Stroke, run by Chinese University of Hong Kong at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

As a major breakthrough of acute stroke treatment over the past decade, endovascular thrombectomy (EVT) drastically improved neurological recovery and survival in patients with large vessel occlusion (LVO) ischemic strokes in major clinical trials. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Stroke, Stroke, Acute
What is being tested?
Thrombus analyses and Imaging assessment
How many people
350 participants
Where
3 sitesin 2 countries
Study dates
21 Oct 2022to 31 Dec 2032
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chinese Stroke Population

Who may be able to join

  • Patient who are over 18 years of age.
  • Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

Who cannot join

  • Patient with isolated vertebral artery occlusion not involving the BA.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Bonaventure Yiu Ming IP, MB ChB contact

852-28902002

bonaventureip@cuhk.edu.hk

Thomas Wai Hong LEUNG, MB ChB contact

852-28902002

drtleung@cuhk.edu.hk

3 sites in 2 countries

China2 sites, 2 recruiting
  • Linyi People's Hospital

    Linyi, Shandong, 276000

    Fengyuan Che, MD,PhD, fyche1971@163.com

    Recruiting
  • The Affiliated Hospital of Medical College of Qingdao University

    Qingdao, Shandong, 266000

    Hao Wang, MD, neurology_hao@163.com

    Recruiting

Other trials in China

Hong Kong1 site, 1 recruiting
  • Chinese University of Hong Kong

    Hong Kong

    Bonaventure Yiu Ming IP, MB ChB, 852-28902002, bonaventureip@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effective Translation of Endovascular Thrombectomy Trials Into Real-world Practice in the Asia-Pacific: a Multicenter, Prospective Registry (ENDURE-APAC)

As a major breakthrough of acute stroke treatment over the past decade, endovascular thrombectomy (EVT) drastically improved neurological recovery and survival in patients with large vessel occlusion (LVO) ischemic strokes in major clinical trials. Nevertheless, much remained uncertain about the implementation of scientific evidence of EVT into real-world benefits. For instance, healthcare policies that influence critical time-matrices, endovascular thrombectomy techniques that may enhance success rate or prevent complications, or advanced imaging techniques that allow precise prognosis or expansion of treatment populations, should be evaluated. On the other hand, capturing LVO patients who were not able to undergo EVT may reveal the gap between clinical trials and real-world practice in the Asia-Pacific.

In this multicenter prospective collaboration across the Asian-Pacific, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

Read the detailed description

In this multicenter, prospective, longitudinal study, the investigators aim to evaluate the determinants of effective EVT in the real-world setting.

The investigators shall recruit patient who are over 18 years of age, with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).

Detailed study procedures are as follows:

  1. As the EVT center of the New Territory East Cluster (NTEC), all patients who undergo EVT triage in the NTEC, i.e. patients with suspected LVO, would be assessed by neuro-interventionists from the Prince of Wales Hospital (PWH). Eligibility screening for recruitment under the ENDURE-APAC registry will be carried out simultaneously.
  2. The investigators shall obtain informed consent either from patient or next-of-kin. Informed consent will be obtained from his/her legal guardian or next-of-kin for those incompetent subjects who are willing to participate in the study. Subjects will be reconsented when competent.
  3. After the informed consent, a study identity number will be assigned to each participant. The investigators shall obtain the following data:
  4. Demographic data such as age, gender, date of birth, smoking and drinking habit, pre-morbid functional status (by modified Rankin Scale (mRS)).
  5. Co-morbidities including hypertension, diabetes mellitus, hyperlipidemia, atrial fibrillation, previous strokes, ischemic heart disease, peripheral vascular disease, congestive heart failure, etc.
  6. Concurrent medications including anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, heparin, warfarin), antiplatelet agents (aspirin, clopidogrel, ticagrelor, cilostazol), lipid-lowering agents (simvastatin, atorvastatin, rosuvastatin, pravastatin, fluvastatin, ezetimibe, gemfibrozil, fenofibrate, erenumab), antihypertensive (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta blockers, calcium channel blockers, diuretics, aldosterone antagonists, nitrates, etc.), cytochrome P450 or P-glycoprotein inhibitors (amiodarone, dronedarone, phenytoin, valproate, carbamazepine, levetiracetam, rifampicin, cyclosporin, etc.), non-steroidal anti-inflammatory agents or cyclo-oxygenase2 inhibitors (indomethacin, ibuprofen, diclofenac, celecoxib, etorixocib), glucose lowering drugs (metformin, gliclazide, glimepiride, empagliflozin, dapagliflozin, insulin, exenatide, semaglutide, liraglutide, dulaglutide).
  7. Radiological findings, treatment outcomes and complications (see 2.3.2 and 2.3.4.) will be documented.
  8. Baseline hemoglobin, white blood cell, platelet count, creatinine, sodium, potassium, alanine transferase, alkaline phosphatase, high density lipoprotein cholesterol, low density lipoprotein cholesterol, total cholesterol, triglyceride level, prothrombin time, activated thromboplastin time, fasting glucose, glycated hemoglobin A1c will be documented.
Being tested
Thrombus analyses, Imaging assessment
Medical subject headings
Ischemic Stroke, Stroke, Brain Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thrombus analysesDiagnostic test

    Physical, histology, biochemical or protein expressions of the thrombi obtained from thrombectomy procedures may contain information regarding the etiology of stroke and relevant disease pathology. The investigators shall store the thrombus, if any, yielded from thrombectomy procedures for future analyses.

  • Imaging assessmentDiagnostic test

    All imaging data will be deidentified before assessment. Plain computer tomography of the brain (CT brain), CT angiography (CTA), CT perfusion (CTP), magnetic resonance imaging of the brain (MRI), digital subtraction imaging (DSA) will be analysed. The investigators shall blind the assessors from treatment choice and outcome in all analyses that require human assessment.

Study groups in NCT05578300
Study groupRoleWhat they receive
Patient with ischemic stroke with suspected large vessel occlusionThe investigators shall recruit patients that meet the following inclusion criteria: 1. Patient who are over 18 years of age. 2. Patient with ischemic stroke with suspected large vessel occlusion (LVO), defined as occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery (BA).
Receives: Diagnostic Test: Thrombus analyses; Diagnostic Test: Imaging assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pre-morbid functional status assessed by modified Rankin Scale (mRS)

    Neurological recover and survival as assessed by mRS at 90 days, with the scale runs from 0-6, running from perfect health without symptoms (Score 0) to death (Score 6).

    Measured: 18 October 2032

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start21 Oct 2022
  3. Primary completion20 Oct 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05578300
Sponsor's protocol ID
CREC 2022.414
Status last verified
Mar 2026
First submitted
11 Oct 2022
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke and Stroke, run by Chinese University of Hong Kong at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bonaventure Yiu Ming IP, MB ChB (852-28902002, bonaventureip@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pre-morbid functional status assessed by modified Rankin Scale (mRS) (time frame: 18 October 2032). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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