Acute Ischemic StrokePhase 3NCT06677970
Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
A Phase 3 study testing BP lowering drugs (nicardipine, labetalol, urapidil) and BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil) in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
Trial summary
Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- BP lowering drugs (nicardipine, labetalol, urapidil) and BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2024to 3 Dec 2029
- Phase
- Phase 3
- 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
<Inclusion Criteria>
- Age ≥20 years
- Acute ischemic stroke patients who underwent intraarterial thrombectomy for large vessel occlusion. (ICA, M1, M2, A1, P1, VA and BA)
- Patients with successful recanalization after intraarterial thrombectomy (TICI 2b or TICI 3)
- Patients with sustained systolic blood pressure (SBP) <150 mm Hg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
- Patients with mean SBP <150 mmHg within 2 hours after successful recanalization (two measurements ≥2 minutes apart).
<Exclusion Criteria>
- Age <20
- Patients who failed recanalization of the intracranial artery after endovascular thrombectomy (modified TICI ≤ 2a).
- Patients with systolic blood pressure ≥ 150 mmHg after successful recanalization.
- Patients unable to receive antihypertensive medication post-thrombectomy or in whom the investigator believes aggressive blood pressure control could have adverse effects, such as increased risk of hemorrhage.
- Patients who developed symptomatic intracranial hemorrhage before study enrollment, after successful recanalization.
- Patients with contraindications to Phenylephrine.
- Patients with contraindications to antihypertensive medications.
- Patients with pre-stroke functional disability (modified Rankin Scale, mRS ≥3).
- Patients with heart failure and reduced cardiac output, with an ejection fraction (EF) <40%.
- Patients with end-stage renal disease requiring renal replacement therapy, or chronic kidney disease stage 4 with an eGFR <30 mL/min.
- Patients currently taking monoamine oxidase (MAO) inhibitors.
- Patients with persistent bradycardia with a heart rate <45 bpm.
- Pregnant patients.
- Patients with severe medical or surgical comorbidities, including but not limited to: terminal cancer with life expectancy <6 months, severe cardiac or aortic disease, severe hematologic disorders, advanced chronic heart failure, severe pneumonia, or sepsis.
- Patients who do not consent to participate in the study.
- Patients participating in another study that does not allow co-enrollment.
- Patients whom the investigator deems unsuitable for study participation for any reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Department of Neurology, Yonsei University College of Medicine
Seoul, Seoul, 120-752
Hyo Suk Nam, MD, PhD, +82 02 2228 1617, hsnam@yuhs.ac
About this study
Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion.
Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in patients with sustained systolic blood pressure (SBP) <150 mmHg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at less than 160 mmHg) or a standard BP control group (systolic BP at or below 180 mmHg).
Read the detailed description
- This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design.
- Participants will be randomly assigned in a 1:1 ratio to either an intensive BP control group (targeting a 20% increase from baseline systolic BP, capped at less than 160 mmHg) or a standard BP control group (maintaining systolic BP at or below 180 mmHg).
- Randomization: Allocation will be stratified by stroke severity (NIHSS <15 or ≥15) and participating study center. Randomization will be conducted via a web-based system using a pre-generated randomization table created by a statistician. Investigators will enter stratification variables (study center, NIHSS score) into the system to receive the randomized allocation.
- This is a multi-center prospective study involving patients admitted to participating hospitals for acute ischemic stroke between October 2024 and December 2029 (last visit date). The study will include patients who undergo successful intra-arterial reperfusion therapy based on current stroke guidelines.
- Data collection will include the medical history, imaging findings, BP parameters (systolic BP, diastolic BP, BP variability), neurological scores, functional recovery, and quality of life (QoL) measures for eligible participants.
- Neurological scores, functional recovery, and QoL assessments will be conducted by independent evaluators who are blinded to treatment allocation.
- All data will be collected using electronic case report forms (e-CRF), and anonymized imaging data will be sent to the coordinating center.
- The coordinating center will perform blinded quantification of imaging results.
- Conditions
- Acute Ischemic Stroke
- Being tested
- BP lowering drugs (nicardipine, labetalol, urapidil), BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)
- Keywords
- Blood pressure, Ischemic stroke, thrombectomy, outcome
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP lowering drugs (nicardipine, labetalol, urapidil)Drug
After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)Drug
After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered.
| Study group | Role | What they receive |
|---|---|---|
| Conventional BP magnagement group (SBP ≤180 mmHg) | Active comparator | Not described Receives: Drug: BP lowering drugs (nicardipine, labetalol, urapidil) |
| Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg ) | Active comparator | Not described Receives: Drug: BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functinal independence
Proportion of patients with a functional independence (defined as mRS ≤ 2) at 3 months, assessed using the modified Rankin Scale (mRS).
Measured: 3 months
Symptomatic Intracranial Hemorrhage (sICH)
Symptomatic Intracranial Hemorrhage (sICH) after Endovascular Treatment Intracranial hemorrhage or hemorrhagic transformation identified on MRI (GRE or SWI) or CT within 24 ± 12 hours or due to clinical worsening.
(Symptomatic intracranial hemorrhage is defined according to the European Cooperative Acute Stroke Study III [ECASS III] criteria)
Measured: 36 hours
Stroke related death
Stroke related death within 3 months
Measured: 3 months
Secondary outcomes (32)
Shift analysis of mRS score distribution.
Distributional analysis of the modified Rankin Scale (mRS) scores to assess overall functional outcome shift between treatment groups.
Measured: 3 months
NIHSS score at 24 hours after endovascular treatment.
Difference in National Institutes of Health Stroke Scale (NIHSS) scores between at 24 hours post-EVT.
Measured: 24 hours
Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.
Proportion of patients achieving substantial neurological recovery within 24 hours after EVT.
Measured: 3 months
Sustained vessel recanalization on CTA/MRA at 24 hours
Evaluation of angiographic reperfusion status (modified Thrombolysis in Cerebral Infarction [mTICI] grade ≥2b)
Measured: Discharge and 1 month
Proportion of functional independence at 1 month.
Percentage of patients achieving mRS 0-2 at 1 month.
Measured: 3 months
Differences in Euro-Q5 instrument.
Differences in scores measured by Euro-Q5 scale.
Measured: 36 hours to 1 week
Incidence of malignant cerebral edema.
Frequency of radiologically or clinically confirmed malignant cerebral edema after EVT.
Measured: 36 hours
Infarction volumes
Proportion of functional independence according to infarction volumes in DWI
Measured: 36 hours
Using intravenous BP lowering drug
Proportion of functional independence according to intrvenous BP lowering drug
Measured: 3 months
Medication induced BP drop
Proportion of functional independence according to medication inuced BP drop
Measured: 3 months
Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2-3) in baseline CTA.
Proportion of functional independence according to the degree of collateral flow
Measured: 3 months
Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).
Evaluation of outcome associations with multiple BP variability indices
Measured: 3 months
Outcome comparison by baseline ischemic core burden measured with ASPECTS.
Proportion of functional independence according to the ASPECTS (Alberta Stroke Program Early CT Score) on CT or MRI.
Measured: 3 months
Evaluation of differential outcomes in patients who received IV tPA before EVT.
Proportion of functional independence according to prior tPA administration.
Measured: 3 months
Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.
Proportion of functional independence according to intracranial arterial stenosis.
Measured: 3 months
Assessment of outcome differences by number of thrombectomy passes.
Proportion of functional independence according to multiple attempts at endovascular recanalization.
Measured: 3 months
Evaluation of outcomes relative to attainment and timing of post-EVT BP target.
Proportion of functional independence according to achieving the target blood pressure and the time to target on outcomes.
Measured: 3 months
Outcome comparison by initial angiographic reperfusion grade before BP intervention.
Proportion of functional independence according to baseline mTICI scores.
Measured: 3 months
Assessment of outcome differences between patients with and without early neurological worsening.
Proportion of functional independence according to neurological deterioration (NIHSS worsening by ≥4 points).
Measured: 3 months
Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).
Proportion of functional independence according to the occluded vessel involved.
Measured: 3 months
Biochemical markers including D-dimer, CRP, or glucose
Proportion of functional independence according to laboratory findings including D-dimer, CRP, or glucose.
Measured: 3 months
Evaluation of vascular stiffness as a determinant of post-EVT outcomes.
Proportion of functional independence according to estimated pulse wave velocity (ePWV).
Measured: 3 months
Small artery disease - white matter hyperintensity
Proportion of functional independence according to degree of white matter hyperintensity
Measured: 3 months
Small artery disease - microbleeds
Proportion of functional independence according to number of microbleeds
Measured: 3 months
Small artery disease - old lacunar infarction
Proportion of functional independence according to number of old lacunar infarctions
Measured: 3 months
Optimal target BP according to AI predicting for functional independence in 10 mmHg increments
Model-based identification of the optimal SBP target range predicted by AI for favorable outcomes.
Measured: 3 months
Occurrence of adverse event or serious adverse event
Incidence and type of adverse events
Measured: 3 months
Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.
Rate of unsuccessful BP target attainment during the acute post-procedure period.
Measured: 24 hours
Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).
Comparison of short-term BP stability between BP medication used for post-EVT management.
Measured: 24 hours
Differences in causes of death.
Comparison of mortality causes
Measured: 3 months
Diffrences in fuctional outcomes at 1 year.
Difference in 1-year functional outcomes according to mRS and EQ-5D-5L.
Measured: 1 year
Euro-Q5-5L analogue scale.
Differnec in scores measured by Euro-Q5 scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Oct 2024
- Primary completion3 Dec 2029 (estimated)
- Study completion3 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a multicenter, randomized, open Lable, blinded end-point clinical trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677970
- Sponsor's protocol ID
- 4-2024-0880
- Status last verified
- Feb 2026
- First submitted
- 23 Sep 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After study competition, the participating researcher can submitt the proposal. Publication committee will evaluate the proposal and approve it. After approval, patients data will be shared with researcher.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)
- ClinicalTrials.gov ID
- NCT06677970
- Acronym / sponsor ID
- 4-2024-0880
- Conditions
- Acute Ischemic Stroke
- Keywords
- Blood pressure, Ischemic stroke, thrombectomy, outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 3 Dec 2029 (estimated)
- Study completion
- 3 Dec 2029 (estimated)
- First posted
- 7 Nov 2024 (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.
Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion.
Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in patients with sustained systolic blood pressure (SBP) <150 mmHg on successive measurements obtained less than 10 minutes apart within 3 hours after reperfusion.
This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at less than 160 mmHg) or a standard BP control group (systolic BP at or below 180 mmHg).
Detailed description
- This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design.
- Participants will be randomly assigned in a 1:1 ratio to either an intensive BP control group (targeting a 20% increase from baseline systolic BP, capped at less than 160 mmHg) or a standard BP control group (maintaining systolic BP at or below 180 mmHg).
- Randomization: Allocation will be stratified by stroke severity (NIHSS <15 or ≥15) and participating study center. Randomization will be conducted via a web-based system using a pre-generated randomization table created by a statistician. Investigators will enter stratification variables (study center, NIHSS score) into the system to receive the randomized allocation.
- This is a multi-center prospective study involving patients admitted to participating hospitals for acute ischemic stroke between October 2024 and December 2029 (last visit date). The study will include patients who undergo successful intra-arterial reperfusion therapy based on current stroke guidelines.
- Data collection will include the medical history, imaging findings, BP parameters (systolic BP, diastolic BP, BP variability), neurological scores, functional recovery, and quality of life (QoL) measures for eligible participants.
- Neurological scores, functional recovery, and QoL assessments will be conducted by independent evaluators who are blinded to treatment allocation.
- All data will be collected using electronic case report forms (e-CRF), and anonymized imaging data will be sent to the coordinating center.
- The coordinating center will perform blinded quantification of imaging results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a multicenter, randomized, open Lable, blinded end-point clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Conventional BP magnagement group (SBP ≤180 mmHg) | Active comparator | Drug: BP lowering drugs (nicardipine, labetalol, urapidil) |
| Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg ) | Active comparator | Drug: BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BP lowering drugs (nicardipine, labetalol, urapidil)After successful reperfusion, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg. | Drug | Conventional BP magnagement group (SBP ≤180 mmHg) |
| BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil)After successful reperfusion, appropriate BP raising (20% increase in SBP, maximum of 160 from baseline SBP) are administered. | Drug | Intensive BP raising group (20% increase in SBP, maximum of 160 mmHg ) |
Primary outcome
Functinal independence
Time frame: 3 months
Proportion of patients with a functional independence (defined as mRS ≤ 2) at 3 months, assessed using the modified Rankin Scale (mRS).
Symptomatic Intracranial Hemorrhage (sICH)
Time frame: 36 hours
Symptomatic Intracranial Hemorrhage (sICH) after Endovascular Treatment Intracranial hemorrhage or hemorrhagic transformation identified on MRI (GRE or SWI) or CT within 24 ± 12 hours or due to clinical worsening. (Symptomatic intracranial hemorrhage is defined according to the European Cooperative Acute Stroke Study III [ECASS III] criteria)
Stroke related death
Time frame: 3 months
Stroke related death within 3 months
32 secondary outcomes
Shift analysis of mRS score distribution.
Time frame: 3 months
NIHSS score at 24 hours after endovascular treatment.
Time frame: 24 hours
Major Neurological Improvement at 24 hours, defined as either an NIHSS score of 0-1 or an improvement of 8 or more points.
Time frame: 3 months
Sustained vessel recanalization on CTA/MRA at 24 hours
Time frame: Discharge and 1 month
Proportion of functional independence at 1 month.
Time frame: 3 months
Differences in Euro-Q5 instrument.
Time frame: 36 hours to 1 week
Incidence of malignant cerebral edema.
Time frame: 36 hours
Infarction volumes
Time frame: 36 hours
Using intravenous BP lowering drug
Time frame: 3 months
Medication induced BP drop
Time frame: 3 months
Collateral circulation measured by Tan scale (good collateral is defined as Tan scale 2-3) in baseline CTA.
Time frame: 3 months
Variability in blood pressure (e.g., standard deviation, coefficient of variation, VIM, successive variation, and threshold).
Time frame: 3 months
Outcome comparison by baseline ischemic core burden measured with ASPECTS.
Time frame: 3 months
Evaluation of differential outcomes in patients who received IV tPA before EVT.
Time frame: 3 months
Comparison of outcomes according to presence or severity of intracranial atherosclerotic stenosis.
Time frame: 3 months
Assessment of outcome differences by number of thrombectomy passes.
Time frame: 3 months
Evaluation of outcomes relative to attainment and timing of post-EVT BP target.
Time frame: 3 months
Outcome comparison by initial angiographic reperfusion grade before BP intervention.
Time frame: 3 months
Assessment of outcome differences between patients with and without early neurological worsening.
Time frame: 3 months
Evaluation of outcomes stratified by occlusion site (e.g., ICA, M1, M2).
Time frame: 3 months
Biochemical markers including D-dimer, CRP, or glucose
Time frame: 3 months
Evaluation of vascular stiffness as a determinant of post-EVT outcomes.
Time frame: 3 months
Small artery disease - white matter hyperintensity
Time frame: 3 months
Small artery disease - microbleeds
Time frame: 3 months
Small artery disease - old lacunar infarction
Time frame: 3 months
Optimal target BP according to AI predicting for functional independence in 10 mmHg increments
Time frame: 3 months
Occurrence of adverse event or serious adverse event
Time frame: 3 months
Treatment failure, defined as failure to achieve target blood pressure on two consecutive measurements within 24 hours after endovascular therapy.
Time frame: 24 hours
Differences in BP variability depending on the antihypertensive agent use (labetalol or nicardipine).
Time frame: 24 hours
Differences in causes of death.
Time frame: 3 months
Diffrences in fuctional outcomes at 1 year.
Time frame: 1 year
Euro-Q5-5L analogue scale.
Time frame: 1 year
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 13 Feb 2026.
- Individual participant dataSharing planned: Yes. After study competition, the participating researcher can submitt the proposal. Publication committee will evaluate the proposal and approve it. After approval, patients data will be shared with researcher.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BP lowering drugs (nicardipine, labetalol, urapidil) and BP raising drug (phenylephrine) or BP lowering drugs (nicardipine, labetalol, urapidil) in people with Acute Ischemic Stroke, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Feb 2026. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hyo Suk Nam, MD,PhD (82-2-2228-1617, hsnam@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functinal independence (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Feb 2026.