Stroke, IschemicTREAT-AISNCT05281055
Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke
An observational study of Stroke, Ischemic, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Endovascular thrombectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2019to 31 Dec 2030
- How long will I take part?
- 3 Months
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke caused by intracranial large vessel occlusion who can be treated within 24 hours of stroke onset.
Who may be able to join
- 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).
Who cannot join
- Other cause of stroke, such as intracranial hemorrhage.
- Not underwent endovascular thrombectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Sung-Chun Tang, MD, PhD, 886223123456 ext. 61244, sctang@ntuh.gov.tw
About this study
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.
Read the 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
- Being tested
- Endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular thrombectomyProcedure or surgery
Timely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombosuction, others, or combination methods.
| Study group | Role | What they receive |
|---|---|---|
| EVT group | Patients who received endovascular thrombectomy for acute ischemic stroke with large vessel occlusion. Receives: Procedure: Endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Functional outcome by modified Rankin scale at 90 days post-stroke
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 3,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-Chun Tang, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281055
- Sponsor's protocol ID
- 201708026RINA
- Acronym
- TREAT-AIS
- Status last verified
- Mar 2022
- First submitted
- 6 Mar 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Registry of Endovascular Thrombectomy for Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05281055
- Acronym / sponsor ID
- TREAT-AIS / 201708026RINA
- Conditions
- Stroke, Ischemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVT group | – | Procedure: Endovascular thrombectomyPatients who received endovascular thrombectomy for acute ischemic stroke with large vessel occlusion. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke caused by intracranial large vessel occlusion who can be treated within 24 hours of stroke onset.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Other cause of stroke, such as intracranial hemorrhage.
- Not underwent endovascular thrombectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular thrombectomyTimely thrombectomy for acute ischemic stroke patients with large vessel occlusion by either stent retriever, thrombosuction, others, or combination methods. | Procedure or surgery | EVT group |
Primary outcome
Functional outcome
Time frame: 90 days
Functional outcome by modified Rankin scale at 90 days post-stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung-Chun Tang, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 2 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Sung-Chun Tang, MD, PhD (886223123456, sctang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome (time frame: 90 days). 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 15 Mar 2022.