Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke

NCT ID: NCT05281055

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2030-12-31

Brief 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.

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.

Conditions

Stroke, Ischemic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EVT group

Patients who received endovascular thrombectomy for acute ischemic stroke with large vessel occlusion.

Endovascular thrombectomy

Intervention Type: PROCEDURE

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

Interventions

Endovascular thrombectomy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sung-Chun Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Sung-Chun Tang, MD, PhD

Role: CONTACT

sctang@ntuh.gov.tw

886223123456

Facility Contacts

Sung-Chun Tang, MD, PhD

Role: primary

sctang@ntuh.gov.tw

886223123456 ext. 61244

Other Identifiers

201708026RINA

Identifier Type: -

Identifier Source: org_study_id