Acute Coronary Syndromes (ACS)SAINT-IVUSNCT07512778
IVUS-Guided vs Angiography-Guided PCI in Acute Coronary Syndrome
A study testing IVUS-guided PCI and Angiography-guided PCI in people with Acute Coronary Syndromes (ACS), run by SUK MIN SEO at 1 site in South Korea.
Trial summary
Coronary artery disease is associated with substantial morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) is a pivotal procedure for the treatment of coronary artery disease. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS)
- What is being tested?
- IVUS-guided PCI and Angiography-guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Mar 2025to 31 Dec 2031
- Phase
- Interventional
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 19 years of age or older
- Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI.
- Coronary artery disease defined as >70% stenosis (reference vessel diameter 2.5 - 5.0 mm based on operator assessment) with identifiable culprit lesion indicated stent implantation
- All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- Age >90 years
- Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated.
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure.
- Cardiogenic shock
- Restenotic lesions
Show all 13Show fewer
- Compromised left ventricular dysfunction (LVEF <30%)
- At the time of screening, the subject has a malignancy that is not in remission
- Non-cardiac co-morbidities with a life expectancy less than 1 year
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Subject belongs to a vulnerable population (per investigator's judgment) or subject unable to read or write
- Concern for inability of the patient to comply with study procedures and/or follow-up (e.g., alcohol or drug abuse)
- Pregnancy
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
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Eunpyeong-gu, 03312
SUK MIN SEO, Assisted Professor, 82+010-9090-8491, ssm530@catholic.ac.kr
YUN JU KANG, 82+010-7358-5252, yunju423@naver.com
About this study
Official title: Clinical Impact of Intravascular Ultrasound-guided vs. Angiography-guided Coronary Stenting in Patients With Acute Coronary Syndrome: Multicenter, Randomized Control Trial (SAINT-IVUS)
Coronary artery disease is associated with substantial morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) is a pivotal procedure for the treatment of coronary artery disease. Although coronary angiography (CA) is the standard imaging modality used for coronary stent implantation, it provides only two-dimensional images of the coronary arteries. Intravascular ultrasound (IVUS) can provide additional information on plaque characteristics and vessel morphology, which may facilitate optimal stent sizing and procedural optimization. However, IVUS requires additional time and cost and may increase procedural complexity. Evidence regarding the clinical benefit of IVUS-guided PCI in patients with acute coronary syndrome (ACS) remains limited.
This study is a prospective, multicenter, randomized controlled trial designed to compare IVUS-guided PCI versus angiography-guided PCI in patients with ACS. A total of 1,500 participants will be randomized 1:1 to either the IVUS-guided group or the angiography-guided group. Participants will be recruited from 15 PCI centers in Korea. The primary outcome is target vessel failure at 2 years.
Read the detailed description
Coronary artery disease is a condition characterized by a high incidence and mortality rate globally. Percutaneous coronary intervention (PCI) stands as a pivotal procedure in the diagnosis and treatment of this disease. Although coronary angiography (CA) is the standard imaging used in coronary stent implantation, it has a limitation in that it only provides two-dimensional images of the coronary arteries. To overcome this limitation, intravascular ultrasound (IVUS) can be utilized, allowing for the visualization of three-dimensional images such as intravascular plaque and morphological characteristics within the vessel, thereby offering more detailed information essential for optimal stent placement. Theoretically, IVUS-guided drug-eluting stent insertion could bring about a reduction in major cardiac events in patients with complex lesions and those at high risk, but most studies have excluded patients with acute coronary syndrome (ACS). The utilization of IVUS demands additional costs and time and might escalate the risk of intravascular complications in certain circumstances. However, the use of IVUS can facilitate a more accurate evaluation of plaque properties and morphology, assisting in determining more effective treatment strategies, and potentially contributing to lowering the risk of major cardiac events in patients suffering from acute myocardial infarction.
The objective of this study is to observe and compare the clinical impact between IVUS-guided drug-eluting stent insertion and angiography-guided drug-eluting stent insertion in patients with ACS over a span of 24 months. To this end, the investigators have planned a prospective, multi-institutional, randomized controlled trial, setting the primary outcome measurement as the target vessel failure rate over two years. The study will encompass 1500 patients, who will be assigned randomly at a 1:1 ratio to either the IVUS-guided or angiography-guided groups. The study participants will be recruited from 15 leading domestic PCI centers.
This research intends to chart the future course of ACS treatment, aspiring to surmount the current limitations of the technologies being employed. It is anticipated that in patients with ACS, IVUS-guided stent insertion during drug-eluting stent implantation might present superior clinical long-term prognoses compared to simple angiography-guided insertion.
- Conditions
- Acute Coronary Syndromes (ACS)
- Being tested
- IVUS-guided PCI, Angiography-guided PCI
- Keywords
- Intravascular Ultrasound, IVUS-guided PCI, Angiography-guided PCI
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVUS-guided PCIProcedure or surgery
Patients randomized to the IVUS-guided PCI arm will undergo percutaneous coronary intervention with intravascular ultrasound guidance. IVUS may be used before, during, and after PCI, and post-stent IVUS assessment will be mandatory. IVUS will be used to determine reference vessel dimensions, guide stent sizing and length selection, and optimize stent expansion and apposition according to predefined criteria. Optimization criteria include adequate stent expansion (minimal lumen area ≥90% of the average reference lumen area), absence of major malapposition, absence of major edge dissection, and absence of significant residual stenosis near the stent edges. If these criteria are not met, additional balloon dilation or stent implantation may be performed at the operator's discretion.
Angiography-guided PCIProcedure or surgery
Patients randomized to the angiography-guided PCI arm will undergo percutaneous coronary intervention guided by conventional coronary angiography. Stent sizing, length selection, and procedural optimization will be performed according to standard angiographic assessment at the operator's discretion. Routine use of intravascular ultrasound will not be routinely performed in this group. However, IVUS may be used only in bailout situations if deemed necessary by the operator.
| Study group | Role | What they receive |
|---|---|---|
| IVUS-guided PCI | Experimental | PCI will be performed under IVUS guidance. Post-stent IVUS assessment is mandatory, and procedural optimization will be performed according to predefined IVUS criteria. Additional balloon dilation or stent implantation may be performed at the operator's discretion if optimization criteria are not met. Receives: Procedure: IVUS-guided PCI |
| Angiography-guided PCI | Active comparator | PCI will be performed under coronary angiography guidance. Routine IVUS use is not planned. IVUS may be used only for bailout situations at the operator's discretion. Receives: Procedure: Angiography-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
Measured: 2 years after randomization
Secondary outcomes (11)
Cardiac death
Death resulting from immediate cardiac causes including myocardial infarction, heart failure, arrhythmia, or other cardiac conditions
Measured: 2 years after randomization
Target vessel-related myocardial infarction
Myocardial infarction attributable to the target vessel treated during the index PCI according to the Fourth Universal Definition of Myocardial Infarction.
Measured: 2 years after randomization
Clinically driven target vessel revascularization
Repeat percutaneous coronary intervention or coronary artery bypass grafting of the target vessel due to symptoms or objective evidence of myocardial ischemia.
Measured: 2 years after randomization
All-cause death
Death from any cause.
Measured: 2 years after randomization
Rate of participants with myocardial infarction (periprocedural MI or spontaneous MI)
Myocardial infarction defined according to the Fourth Universal Definition of Myocardial Infarction.
Measured: 2 years after randomization
Rate of participants with any coronary revascularization
target vessel vs. non-target vessel, target lesion vs. non-target lesion, clinically driven vs. non-clinically driven
Measured: 2 years after randomization
Rate of participants with definite or probable stent thrombosis
Definite or probable stent thrombosis defined according to the Academic Research Consortium (ARC) criteria.
Measured: 2 years after randomization
Procedural success
Successful PCI with residual stenosis <30% and final TIMI 3 flow in the treated vessel without in-hospital major adverse cardiac events.
Measured: Periprocedural (index PCI)
Total procedural time
Measured: Periprocedural (index PCI)
Total amount of contrast use
Measured: Periprocedural (index PCI)
Incidence of contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure
Measured: 72 hours after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start13 Mar 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SUK MIN SEO
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Korea Co. Ltd
- Responsible party
- Sponsor-investigator, SUK MIN SEO, Eunpyeong St. Mary's Hospital
- Investigators
- Suk Min Seo, MD, PhD, Principal investigator, The Catholic University of Korea Eunpyeong St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512778
- Sponsor's protocol ID
- PC23EIDE0191
- Other IDs
- KCT0009756
- Acronym
- SAINT-IVUS
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available because of institutional policy and patient confidentiality considerations.
Publications
Schiele F, Meneveau N, Vuillemenot A, Zhang DD, Gupta S, Mercier M, Danchin N, Bertrand B, Bassand JP. Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies--with and without intravascular ultrasound guidance. RESIST Study Group. REStenosis after Ivus guided STenting. J Am Coll Cardiol. 1998 Aug;32(2):320-8. doi: 10.1016/s0735-1097(98)00249-6.
PubMed 9708456Darmoch F, Alraies MC, Al-Khadra Y, Moussa Pacha H, Pinto DS, Osborn EA. Intravascular Ultrasound Imaging-Guided Versus Coronary Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Mar 3;9(5):e013678. doi: 10.1161/JAHA.119.013678. Epub 2020 Feb 20.
PubMed 32075491
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Impact of Intravascular Ultrasound-guided vs. Angiography-guided Coronary Stenting in Patients With Acute Coronary Syndrome: Multicenter, Randomized Control Trial (SAINT-IVUS)
- ClinicalTrials.gov ID
- NCT07512778
- Acronym / sponsor ID
- SAINT-IVUS / PC23EIDE0191
- Conditions
- Acute Coronary Syndromes (ACS)
- Keywords
- Intravascular Ultrasound, IVUS-guided PCI, Angiography-guided PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- SUK MIN SEOUniversity, hospital or other
- Collaborators
- Boston Scientific Korea Co. Ltd
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Apr 2026 (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.
Coronary artery disease is associated with substantial morbidity and mortality worldwide. Percutaneous coronary intervention (PCI) is a pivotal procedure for the treatment of coronary artery disease. Although coronary angiography (CA) is the standard imaging modality used for coronary stent implantation, it provides only two-dimensional images of the coronary arteries. Intravascular ultrasound (IVUS) can provide additional information on plaque characteristics and vessel morphology, which may facilitate optimal stent sizing and procedural optimization. However, IVUS requires additional time and cost and may increase procedural complexity. Evidence regarding the clinical benefit of IVUS-guided PCI in patients with acute coronary syndrome (ACS) remains limited.
This study is a prospective, multicenter, randomized controlled trial designed to compare IVUS-guided PCI versus angiography-guided PCI in patients with ACS. A total of 1,500 participants will be randomized 1:1 to either the IVUS-guided group or the angiography-guided group. Participants will be recruited from 15 PCI centers in Korea. The primary outcome is target vessel failure at 2 years.
Detailed description
Coronary artery disease is a condition characterized by a high incidence and mortality rate globally. Percutaneous coronary intervention (PCI) stands as a pivotal procedure in the diagnosis and treatment of this disease. Although coronary angiography (CA) is the standard imaging used in coronary stent implantation, it has a limitation in that it only provides two-dimensional images of the coronary arteries. To overcome this limitation, intravascular ultrasound (IVUS) can be utilized, allowing for the visualization of three-dimensional images such as intravascular plaque and morphological characteristics within the vessel, thereby offering more detailed information essential for optimal stent placement. Theoretically, IVUS-guided drug-eluting stent insertion could bring about a reduction in major cardiac events in patients with complex lesions and those at high risk, but most studies have excluded patients with acute coronary syndrome (ACS). The utilization of IVUS demands additional costs and time and might escalate the risk of intravascular complications in certain circumstances. However, the use of IVUS can facilitate a more accurate evaluation of plaque properties and morphology, assisting in determining more effective treatment strategies, and potentially contributing to lowering the risk of major cardiac events in patients suffering from acute myocardial infarction.
The objective of this study is to observe and compare the clinical impact between IVUS-guided drug-eluting stent insertion and angiography-guided drug-eluting stent insertion in patients with ACS over a span of 24 months. To this end, the investigators have planned a prospective, multi-institutional, randomized controlled trial, setting the primary outcome measurement as the target vessel failure rate over two years. The study will encompass 1500 patients, who will be assigned randomly at a 1:1 ratio to either the IVUS-guided or angiography-guided groups. The study participants will be recruited from 15 leading domestic PCI centers.
This research intends to chart the future course of ACS treatment, aspiring to surmount the current limitations of the technologies being employed. It is anticipated that in patients with ACS, IVUS-guided stent insertion during drug-eluting stent implantation might present superior clinical long-term prognoses compared to simple angiography-guided insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS-guided PCI | Experimental | Procedure: IVUS-guided PCIPCI will be performed under IVUS guidance. Post-stent IVUS assessment is mandatory, and procedural optimization will be performed according to predefined IVUS criteria. Additional balloon dilation or stent implantation may be performed at the operator's discretion if optimization criteria are not met. |
| Angiography-guided PCI | Active comparator | Procedure: Angiography-guided PCIPCI will be performed under coronary angiography guidance. Routine IVUS use is not planned. IVUS may be used only for bailout situations at the operator's discretion. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 19 years of age or older
- Patients with unstable angina pectoris, and acute MI including NSTEMI or STEMI.
- Coronary artery disease defined as >70% stenosis (reference vessel diameter 2.5 - 5.0 mm based on operator assessment) with identifiable culprit lesion indicated stent implantation
- All lesions must be suitable for treatment with the Synergy stent system, or other Synergy platform iteration
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (13 listed)
- Age >90 years
- Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly(L-lactide), poly(DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoro polymers that cannot be adequately premedicated.
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs within 6 m after the procedure.
- Cardiogenic shock
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 |
|---|---|---|
| IVUS-guided PCIPatients randomized to the IVUS-guided PCI arm will undergo percutaneous coronary intervention with intravascular ultrasound guidance. IVUS may be used before, during, and after PCI, and post-stent IVUS assessment will be mandatory. IVUS will be used to determine reference vessel dimensions, guide stent sizing and length selection, and optimize stent expansion and apposition according to predefined criteria. Optimization criteria include adequate stent expansion (minimal lumen area ≥90% of the average reference lumen area), absence of major malapposition, absence of major edge dissection, and absence of significant residual stenosis near the stent edges. If these criteria are not met, additional balloon dilation or stent implantation may be performed at the operator's discretion. | Procedure or surgery | IVUS-guided PCI |
| Angiography-guided PCIPatients randomized to the angiography-guided PCI arm will undergo percutaneous coronary intervention guided by conventional coronary angiography. Stent sizing, length selection, and procedural optimization will be performed according to standard angiographic assessment at the operator's discretion. Routine use of intravascular ultrasound will not be routinely performed in this group. However, IVUS may be used only in bailout situations if deemed necessary by the operator. | Procedure or surgery | Angiography-guided PCI |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 2 years after randomization
Composite of cardiac death, target vessel-related myocardial infarction, or clinically driven target vessel revascularization.
11 secondary outcomes
Cardiac death
Time frame: 2 years after randomization
Target vessel-related myocardial infarction
Time frame: 2 years after randomization
Clinically driven target vessel revascularization
Time frame: 2 years after randomization
All-cause death
Time frame: 2 years after randomization
Rate of participants with myocardial infarction (periprocedural MI or spontaneous MI)
Time frame: 2 years after randomization
Rate of participants with any coronary revascularization
Time frame: 2 years after randomization
Rate of participants with definite or probable stent thrombosis
Time frame: 2 years after randomization
Procedural success
Time frame: Periprocedural (index PCI)
Total procedural time
Time frame: Periprocedural (index PCI)
Total amount of contrast use
Time frame: Periprocedural (index PCI)
Incidence of contrast-induced nephropathy, defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure
Time frame: 72 hours after index procedure
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 6 Apr 2026.
- Background: PubMed 9708456Schiele F, Meneveau N, Vuillemenot A, Zhang DD, Gupta S, Mercier M, Danchin N, Bertrand B, Bassand JP. Impact of intravascular ultrasound guidance in stent deployment on 6-month restenosis rate: a multicenter, randomized study comparing two strategies--with and without intravascular ultrasound guidance. RESIST Study Group. REStenosis after Ivus guided STenting. J Am Coll Cardiol. 1998 Aug;32(2):320-8. doi: 10.1016/s0735-1097(98)00249-6.
- Background: PubMed 32075491Darmoch F, Alraies MC, Al-Khadra Y, Moussa Pacha H, Pinto DS, Osborn EA. Intravascular Ultrasound Imaging-Guided Versus Coronary Angiography-Guided Percutaneous Coronary Intervention: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2020 Mar 3;9(5):e013678. doi: 10.1161/JAHA.119.013678. Epub 2020 Feb 20.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available because of institutional policy and patient confidentiality considerations.
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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.
Suk Min Seo, MD, PhD principal investigator
The Catholic University of Korea Eunpyeong St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVUS-guided PCI and Angiography-guided PCI in people with Acute Coronary Syndromes (ACS), run by SUK MIN SEO 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?
The sponsor lists 5 inclusion and 13 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 6 Apr 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.
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 SUK MIN SEO, Assisted Professor (82+010-9090-8491, ssm530@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 2 years after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07512778, which also lists 2 linked publications.
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 6 Apr 2026.