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

NCT05578300 | Recruiting

• 1 other identifier: CREC 2022.414
• Study Type: observational
• Target: 350
• Locations: 2 countries
• Sites: 3

Brief 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. 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.

Conditions

Ischemic Stroke; Stroke; Stroke, Acute; Stroke, Ischemic; Brain Diseases; Major Adverse Cardiovascular Event

Outcome Measures

Primary Outcomes (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).

  18 October 2032

Study Arms (1)

Patient with ischemic stroke with suspected large vessel occlusion

The 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).

Diagnostic Test: Thrombus analyses; Diagnostic Test: Imaging assessment

Interventions

Thrombus analyses DIAGNOSTIC_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.

Patient with ischemic stroke with suspected large vessel occlusion

Imaging assessment DIAGNOSTIC_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.

Patient with ischemic stroke with suspected large vessel occlusion

Eligibility Criteria

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

Study Population

Chinese Stroke Population

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Linyi People's Hospital: collaborator

Study Sites (3)

Linyi People's Hospital

Linyi, Shandong, 276000, China

RECRUITING

The Affiliated Hospital of Medical College of Qingdao University

Qingdao, Shandong, 266000, China

RECRUITING

Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Brain Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bonaventure Yiu Ming IP, MB ChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: October 21, 2022
• Primary Completion (Estimated): October 20, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); CN (2)