Coronary Artery DiseaseDCB-SVDNCT07839806
Drug-coated Balloons Versus Drug-eluting Stents for de Novo Small-vessel Coronary Artery Disease
An observational study of Coronary Artery Disease, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Drug coated balloon and Drug Eluting stent
- Type of treatment
- Medical device
- How many people
- 230 participants
- Where
- 1 siteGreece
- Study dates
- 3 Oct 2024to 3 Oct 2027
- How long will I take part?
- 12 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients with chronic coronary syndrome or non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease at participating centers will be considered for inclusion. Eligible lesions will be located in native coronary arteries with a reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Patients will be included in the drug-coated balloon or second-generation drug-eluting stent cohort according to the treatment selected by the treating interventional cardiologist during routine clinical care. Treatment allocation will not be randomized or determined by the study protocol.
Who may be able to join
- Age 18 years or older. Chronic coronary syndrome or non-ST-elevation acute coronary syndrome requiring percutaneous coronary intervention.
- De novo lesion in a native coronary artery. Reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Angiographic diameter stenosis greater than 70%. Successful lesion preparation, defined as residual stenosis of 30% or less, TIMI grade 3 flow, and absence of an NHLBI type C-F flow-limiting dissection.
- Treatment with a drug-coated balloon or a second-generation drug-eluting stent, selected at the discretion of the treating interventional cardiologist.
- Ability to provide informed consent and comply with clinical follow-up.
Who cannot join
- ST-elevation myocardial infarction requiring primary percutaneous coronary intervention.
- In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
- Contraindication to antiplatelet therapy or to any component of the devices used.
- Life expectancy of less than 12 months because of a non-cardiovascular condition.
- Pregnancy. Inability to provide informed consent or complete the planned follow-up.
Trial locations and contacts
1 site in 1 country.
Greece1 site
First Department of Cardiology, Medical School of Athens, National and Kapodistrian University of Athens, General Hospital of Athens Ippokrateio, Athens, Greece
Athens, Attica, 11527
About this study
Official title: Drug-Coated Balloons Versus Drug-Eluting Stents for De Novo Small-Vessel Coronary Artery Disease: A Prospective, Multicenter, Non-Randomized Observational Study
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels.
The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.
Read the detailed description
Small-vessel coronary artery disease remains a challenging setting for percutaneous coronary intervention because the limited vessel diameter increases the potential clinical impact of neointimal proliferation and restenosis. Second-generation drug-eluting stents represent an established treatment strategy, whereas drug-coated balloons deliver an antiproliferative agent without leaving a permanent metallic scaffold.
This is a prospective, multicenter, non-randomized observational study of consecutive patients undergoing percutaneous coronary intervention for de novo small-vessel coronary lesions. Lesion preparation and all procedural decisions will be performed according to contemporary clinical practice. Following adequate lesion preparation, the selection of a drug-coated balloon or a second-generation drug-eluting stent will be made by the treating interventional cardiologist on the basis of clinical, angiographic, and procedural considerations. The study protocol does not assign treatment and does not alter routine patient care.
Baseline demographic and clinical characteristics, angiographic findings, lesion characteristics, procedural details, device-related information, and in-hospital events will be recorded prospectively. Participants will undergo clinical follow-up for 12 months to document cardiovascular events, repeat coronary revascularization, and other relevant clinical outcomes. Outcomes will be compared between the drug-coated balloon and drug-eluting stent cohorts, taking into consideration the non-randomized nature of treatment selection and potential baseline differences between the groups.
- Conditions
- Coronary Artery Disease
- Being tested
- Drug coated balloon, Drug Eluting stent
- Keywords
- Small vessel coronary artery disease, Coronary artery disease, Drug coated balloon, Drug eluting stent, Percutaneous Coronary Intervention, De Novo Coronary lesion
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug coated balloonDevice
Percutaneous coronary intervention performed using a drug-coated balloon following adequate lesion preparation. Balloon type, diameter, length, inflation pressure, and inflation duration are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. Bailout stent implantation may be performed when clinically required, including in cases of significant residual stenosis, impaired coronary flow, or flow-limiting dissection.
Drug Eluting stentDevice
Percutaneous coronary intervention performed using a second-generation drug-eluting stent following lesion preparation. Stent type, diameter, length, implantation pressure, and post-dilatation strategy are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Balloon Group | Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a drug-coated balloon after adequate lesion preparation. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care. Receives: Device: Drug coated balloon | |
| Drug Eluting Stent Group | Patients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a second-generation drug-eluting stent. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care. Receives: Device: Drug Eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Number of participants experiencing at least one major adverse cardiovascular event, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or clinically driven target lesion revascularization.
Measured: From the index procedure through 12 months
Secondary outcomes (6)
Cardiovascular Death
Measured: Through 12 months
Nonfatal Myocardial Infarction
Measured: Through 12 months
Target Vessel Revascularization
Measured: Through 12 months
Procedural Success
Measured: During the index procedure
Major Bleeding
Measured: During hospitalization and through 12 months
Bailout Stent Implantation
Measured: During the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start3 Oct 2024
- Primary completion3 Dec 2026 (estimated)
- Study completion3 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe 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
- 230 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Sismanoglio General Hospital
- Responsible party
- Principal investigator, Nikolaos Tsiamis, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839806
- Sponsor's protocol ID
- 17650/02102024
- Acronym
- DCB-SVD
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant-level data are not currently planned to be shared because the study consent, institutional data-governance requirements, and applicable data-protection regulations do not provide for public or unrestricted sharing of participant-level clinical data. Aggregate study results may be reported in scientific publications and conference presentations.
Publications
Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Online ahead of print.
PubMed 40272160Fezzi S, Serruys PW, Cortese B, Scheller B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber F, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip D, Krucoff M, Stone GW, Garg S, Onuma Y. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. 2025 Oct 14;86(15):1170-1202. doi: 10.1016/j.jacc.2025.07.049.
PubMed 41062231Fahrni G, Scheller B, Coslovsky M, Gilgen N, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Zweiker R, Twerenbold R, Kaiser C, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2020 Sep;109(9):1114-1124. doi: 10.1007/s00392-020-01603-2. Epub 2020 Jan 29.
PubMed 31993736Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.
PubMed 37164603Tsiamis N, Tsakirian F, Papanikolaou A, Afendoulis D, Toulgaridis F, Dimitriadis K, Tolis I, Tzortzis S, Triantis G, Aghayan S, Tsioufis K, Toutouzas K. Revolutionizing Modern Percutaneous Coronary Intervention: Drug-Coated Balloons for Diabetics With Small Vessel Disease. A Narrative Review. Catheter Cardiovasc Interv. 2026 May;107(6):1922-1933. doi: 10.1002/ccd.70550. Epub 2026 Mar 15.
PubMed 41833545
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloons Versus Drug-Eluting Stents for De Novo Small-Vessel Coronary Artery Disease: A Prospective, Multicenter, Non-Randomized Observational Study
- ClinicalTrials.gov ID
- NCT07839806
- Acronym / sponsor ID
- DCB-SVD / 17650/02102024
- Conditions
- Coronary Artery Disease
- Keywords
- Small vessel coronary artery disease, Coronary artery disease, Drug coated balloon, Drug eluting stent, Percutaneous Coronary Intervention, De Novo Coronary lesion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Sismanoglio General Hospital
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 3 Dec 2026 (estimated)
- Study completion
- 3 Oct 2027 (estimated)
- First posted
- 24 Sep 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.
This prospective, multicenter observational study will compare the safety and clinical outcomes of drug-coated balloon angioplasty and second-generation drug-eluting stent implantation in patients undergoing percutaneous coronary intervention for previously untreated lesions in small coronary vessels.
The treatment strategy will be selected by the treating interventional cardiologist according to the patient's clinical and angiographic characteristics and will not be assigned randomly by the study. Participants will receive standard clinical care and will be followed for 12 months. The study will evaluate major adverse cardiovascular events, including cardiovascular death, myocardial infarction, and the need for repeat treatment of the target lesion. Procedural outcomes and treatment-related complications will also be recorded.
Detailed description
Small-vessel coronary artery disease remains a challenging setting for percutaneous coronary intervention because the limited vessel diameter increases the potential clinical impact of neointimal proliferation and restenosis. Second-generation drug-eluting stents represent an established treatment strategy, whereas drug-coated balloons deliver an antiproliferative agent without leaving a permanent metallic scaffold.
This is a prospective, multicenter, non-randomized observational study of consecutive patients undergoing percutaneous coronary intervention for de novo small-vessel coronary lesions. Lesion preparation and all procedural decisions will be performed according to contemporary clinical practice. Following adequate lesion preparation, the selection of a drug-coated balloon or a second-generation drug-eluting stent will be made by the treating interventional cardiologist on the basis of clinical, angiographic, and procedural considerations. The study protocol does not assign treatment and does not alter routine patient care.
Baseline demographic and clinical characteristics, angiographic findings, lesion characteristics, procedural details, device-related information, and in-hospital events will be recorded prospectively. Participants will undergo clinical follow-up for 12 months to document cardiovascular events, repeat coronary revascularization, and other relevant clinical outcomes. Outcomes will be compared between the drug-coated balloon and drug-eluting stent cohorts, taking into consideration the non-randomized nature of treatment selection and potential baseline differences between the groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Balloon Group | – | Device: Drug coated balloonPatients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a drug-coated balloon after adequate lesion preparation. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care. |
| Drug Eluting Stent Group | – | Device: Drug Eluting stentPatients undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease using a second-generation drug-eluting stent. Treatment selection is made by the treating interventional cardiologist as part of routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients with chronic coronary syndrome or non-ST-elevation acute coronary syndrome undergoing percutaneous coronary intervention for de novo small-vessel coronary artery disease at participating centers will be considered for inclusion. Eligible lesions will be located in native coronary arteries with a reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Patients will be included in the drug-coated balloon or second-generation drug-eluting stent cohort according to the treatment selected by the treating interventional cardiologist during routine clinical care. Treatment allocation will not be randomized or determined by the study protocol.
Key inclusion criteria (4 listed)
- Age 18 years or older. Chronic coronary syndrome or non-ST-elevation acute coronary syndrome requiring percutaneous coronary intervention.
- De novo lesion in a native coronary artery. Reference vessel diameter greater than 2.0 mm and less than 2.75 mm. Angiographic diameter stenosis greater than 70%. Successful lesion preparation, defined as residual stenosis of 30% or less, TIMI grade 3 flow, and absence of an NHLBI type C-F flow-limiting dissection.
- Treatment with a drug-coated balloon or a second-generation drug-eluting stent, selected at the discretion of the treating interventional cardiologist.
- Ability to provide informed consent and comply with clinical follow-up.
Key exclusion criteria (5 listed)
- ST-elevation myocardial infarction requiring primary percutaneous coronary intervention.
- In-stent restenosis. Cardiogenic shock or hemodynamic instability at the time of the index procedure.
- Contraindication to antiplatelet therapy or to any component of the devices used.
- Life expectancy of less than 12 months because of a non-cardiovascular condition.
- Pregnancy. Inability to provide informed consent or complete the planned follow-up.
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 |
|---|---|---|
| Drug coated balloonPercutaneous coronary intervention performed using a drug-coated balloon following adequate lesion preparation. Balloon type, diameter, length, inflation pressure, and inflation duration are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. Bailout stent implantation may be performed when clinically required, including in cases of significant residual stenosis, impaired coronary flow, or flow-limiting dissection. | Device | Drug Coated Balloon Group |
| Drug Eluting stentPercutaneous coronary intervention performed using a second-generation drug-eluting stent following lesion preparation. Stent type, diameter, length, implantation pressure, and post-dilatation strategy are selected by the treating interventional cardiologist according to lesion characteristics and routine clinical practice. | Device | Drug Eluting Stent Group |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: From the index procedure through 12 months
Number of participants experiencing at least one major adverse cardiovascular event, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or clinically driven target lesion revascularization.
6 secondary outcomes
Cardiovascular Death
Time frame: Through 12 months
Nonfatal Myocardial Infarction
Time frame: Through 12 months
Target Vessel Revascularization
Time frame: Through 12 months
Procedural Success
Time frame: During the index procedure
Major Bleeding
Time frame: During hospitalization and through 12 months
Bailout Stent Implantation
Time frame: During the 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 24 Sep 2026.
- Background: PubMed 40272160Fezzi S, Scheller B, Cortese B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber FX, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip DE, Krucoff MW, Stone GW, Garg S, Onuma Y, Serruys PW. Definitions and standardized endpoints for the use of drug-coated balloon in coronary artery disease: consensus document of the Drug Coated Balloon Academic Research Consortium. EuroIntervention. 2025 Apr 24;21(19):e1116-36. doi: 10.4244/EIJ-E-25-00021. Online ahead of print.
- Background: PubMed 41062231Fezzi S, Serruys PW, Cortese B, Scheller B, Alfonso F, Jeger R, Colombo A, Joner M, Shin ES, Kleber F, Latib A, Rissanen TT, Eccleshall S, Ribichini F, Tao L, Koo BK, Chieffo A, Ge J, Granada JF, Stoll HP, Spaulding C, Cavalcante R, Abizaid A, Muramatsu T, Boudoulas KD, Waksman R, Mehran R, Cutlip D, Krucoff M, Stone GW, Garg S, Onuma Y. Indications for Use of Drug-Coated Balloons in Coronary Intervention: Academic Research Consortium Position Statement. J Am Coll Cardiol. 2025 Oct 14;86(15):1170-1202. doi: 10.1016/j.jacc.2025.07.049.
- Background: PubMed 31993736Fahrni G, Scheller B, Coslovsky M, Gilgen N, Farah A, Ohlow MA, Mangner N, Weilenmann D, Wohrle J, Cuculi F, Leibundgut G, Mobius-Winkler S, Zweiker R, Twerenbold R, Kaiser C, Jeger R; BASKET-SMALL 2 Investigators. Drug-coated balloon versus drug-eluting stent in small coronary artery lesions: angiographic analysis from the BASKET-SMALL 2 trial. Clin Res Cardiol. 2020 Sep;109(9):1114-1124. doi: 10.1007/s00392-020-01603-2. Epub 2020 Jan 29.
- Background: PubMed 37164603Cortese B, Testa G, Rivero F, Erriquez A, Alfonso F. Long-Term Outcome of Drug-Coated Balloon vs Drug-Eluting Stent for Small Coronary Vessels: PICCOLETO-II 3-Year Follow-Up. JACC Cardiovasc Interv. 2023 May 8;16(9):1054-1061. doi: 10.1016/j.jcin.2023.02.011. Epub 2023 Apr 19.
- Background: PubMed 41833545Tsiamis N, Tsakirian F, Papanikolaou A, Afendoulis D, Toulgaridis F, Dimitriadis K, Tolis I, Tzortzis S, Triantis G, Aghayan S, Tsioufis K, Toutouzas K. Revolutionizing Modern Percutaneous Coronary Intervention: Drug-Coated Balloons for Diabetics With Small Vessel Disease. A Narrative Review. Catheter Cardiovasc Interv. 2026 May;107(6):1922-1933. doi: 10.1002/ccd.70550. Epub 2026 Mar 15.
- Individual participant dataSharing planned: No. Individual participant-level data are not currently planned to be shared because the study consent, institutional data-governance requirements, and applicable data-protection regulations do not provide for public or unrestricted sharing of participant-level clinical data. Aggregate study results may be reported in scientific publications and conference presentations.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 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 Greece. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: From the index procedure through 12 months). 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 NCT07839806, which also lists 5 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 24 Sep 2026.