Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke

Stroke, Ischemic Clinical Trial

— TREAT-AIS  

Official title:

Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281055
• Other study ID #: 201708026RINA
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2022
• Source: National Taiwan University Hospital
• Contact: Sung-Chun Tang, MD, PhD
• Phone: 886223123456
• Email: sctang[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Procedure:
• Endovascular thrombectomy
Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombosuction, others, or combination methods.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome	Functional outcome by modified Rankin scale at 90 days post-stroke	90 days