Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke (TREAT-AIS)

Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke is a multi-centers registration. It starts in Jan 2019. The key items in the registration form include basic demographic profiles, past medical history, time of stroke onset, stroke severity (NIH stroke scale), whether to have rt-PA treatment, pre-EVT imaging, type of devices, status of recanalization, complication and other associated parameters for EVT, and 3 months post stroke outcome. The study also includes a standardized imaging analysis for the quantification of the de-identified imaging data from participates. In summary, the registry will provide the valuable information for AIS patients receiving EVT in Twain.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Procedure: Endovascular thrombectomy

Detailed Description

Stroke is the second leading cause of death and third leading cause of disability worldwide. Until recently, intravenous recombinant tissue-type plasminogen activator (r-tPA) was the only therapy that was proven to be effective for acute ischemic stroke (AIS). However, the effect of rt-PA was limited in stroke patients with large artery occlusion. In 2015, there were five randomized controlled trials of endovascular therapy (EVT) for AIS. The significant positive results indicated an evolution of treatment for AIS in selected patients. Nevertheless, because previous EVT trials recruited mainly Caucasians as trial participants, little is known about racial differences in endovascular treatment.

In Taiwan, the Ministry of Health and Welfare has approved the application of EVT in AIS and the National Health Insurance also started to pay the devices for EVT in AIS patients fulfilling certain conditions in recent years. Therefore, it is important to have a prospective registration to evaluate the efficacy and safety in AIS patients receiving EVT in Taiwan.

Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke is a multi-centers registration. It starts in Jan 2019. The key items in the registration form include basic demographic profiles, past medical history, time of stroke onset, stroke severity (NIH stroke scale), whether to have rt-PA treatment, pre-EVT imaging, type of devices, status of recanalization, complication and other associated parameters for EVT, and 3 months post stroke outcome. The study also includes a standardized imaging analysis for the quantification of the de-identified imaging data from participates.

In summary, the registry will provide the valuable information for AIS patients receiving EVT in Twain.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Sung-Chun Tang, MD, PhD; Phone Number: 886223123456; Email: sctang@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Sung-Chun Tang, MD, PhD; Phone Number: 61244 886223123456; Email: sctang@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acute ischemic stroke caused by intracranial large vessel occlusion who can be treated within 24 hours of stroke onset.

Description

Inclusion Criteria:

• Acute ischemic stroke caused by intracranial large vessel occlusion
• Can be treated within 24 hours of stroke onset.
• Large vessel occlusion demonstrated by magnetic resonance imaging angiography (MRA), computed tomography angiography (CTA) or digital substraction angiography (DSA).
• Pre-stroke independence (modified Rankin Scale 0-2).

Exclusion Criteria:

• Other cause of stroke, such as intracranial hemorrhage.
• Not underwent endovascular thrombectomy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EVT group; Patients who received endovascular thrombectomy for acute ischemic stroke with large vessel occlusion.	Procedure: Endovascular thrombectomy; Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombosuction, others, or combination methods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome	Functional outcome by modified Rankin scale at 90 days post-stroke	90 days

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Sung-Chun Tang, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2030
• Study Completion (Anticipated): December 31, 2030

Study Registration Dates

• First Submitted: March 6, 2022
• First Submitted That Met QC Criteria: March 6, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: 201708026RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No