Coronary Artery DiseasePOLARISNCT07563231
Polymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Dorian Garin at 1 site in Switzerland.
Trial summary
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2026to Jun 2036
- How long will I take part?
- 5 Years
- 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 who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.
Who may be able to join
- Age >= 18 years at the time of the index procedure.
- Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.
- Implantation of at least one study device
- Indication for PCI according to current European or American guidelines.
- Able and willing to provide written informed consent.
- Sufficient knowledge of French, German, English, or Italian to understand the patient information document.
Who cannot join
- Documented refusal to participate in research through opt-out from general consent.
- Inability to provide informed consent (cognitive impairment or other).
- Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).
- Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.
- Participation in another clinical trial that would interfere with the endpoints of this registry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dorian Garin, MD contact
Switzerland1 site
Geneva University Hospitals (HUG) - Service of Cardiology
Geneva, 1211
Juan F Iglesias, MD, FESC, FACC, +41 22 372 72 00, juanFernando.Iglesias@hug.ch
Dorian Garin, MD, dorian.garin@hug.ch
About this study
Official title: POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.
Read the detailed description
BACKGROUND. Newer-generation drug-eluting stents (DES) remain associated with late stent-related adverse events at approximately 2% per year, driven by neoatherosclerosis, delayed endothelial healing, and chronic inflammation attributable to permanent polymer coatings. Polymer-free DES were developed to remove this substrate. The polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) (after: study device) is a novel polymer-free sirolimus-eluting stent built on a thin-strut (73 micrometres) cobalt-chromium platform, with drug delivery via biodegradable phospholipid submicron carriers (200-300 nm) confined to the abluminal surface, and a proprietary fusion coating extending sirolimus up to 5 mm beyond the stent edges. The device received CE marking on 24 January 2020. Only limited non-randomized Indian clinical data exist; no Western clinical data have been published.
OBJECTIVES. Primary: to evaluate device-oriented safety and efficacy (TLF at 12 months) of the stent in an all-comer population undergoing PCI at Geneva University Hospitals. Secondary: TLF at 2 and 5 years; individual components of TLF (cardiac death, target vessel MI, clinically indicated target lesion revascularisation) at 30 days, 12 months, 2 years, and 5 years; patient-oriented composite endpoint (all-cause death, any MI, any revascularisation); stent thrombosis (definite / probable, ARC-2, with temporal classification); target vessel failure; major bleeding (BARC 3 or 5); all-cause mortality; and late lumen loss when angiographic follow-up is available.
DESIGN. Prospective, single-centre, single-arm observational registry (Category A research with human subjects per the Swiss Human Research Act). Hybrid enrolment: retrospective identification from January 2021, prospective consent, and prospective follow-up at 30 days, 12 months, 2 years, and 5 years via medical records and telephone interview.
POPULATION. All consecutive adult patients (>= 18 years) treated with at least one study device stent at Geneva University Hospitals since January 2021, with an indication for PCI according to current European or American guidelines, able to provide written informed consent, and with sufficient knowledge of French, German, English, or Italian.
STATISTICS. Exploratory, descriptive analysis. Binary endpoints with Clopper-Pearson 95% confidence intervals; time-to-event analysis by Kaplan-Meier with Greenwood 95% CIs. Pre-specified exploratory subgroup analyses (sex, clinical presentation, diabetes, age, lesion complexity, stent length) presented as forest plots without between-group p-values. Sensitivity analyses include per-protocol, complete-case, landmark (30 days to 12 months), Fine-Gray competing-risk, and tipping point analyses. Analyses in Python (lifelines, pandas, scipy, statsmodels). Reporting follows STROBE.
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Stent Thrombosis, Percutaneous Coronary Intervention
- Being tested
- Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)
- Keywords
- drug-eluting stent, polymer-free stent, sirolimus, percutaneous coronary intervention, target lesion failure, registry, real-world evidence
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)Device
Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care.
| Study group | Role | What they receive |
|---|---|---|
| POLARIS cohort | Consecutive adult patients who received at least one polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice. Receives: Device: Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.
Measured: 12 months
Secondary outcomes (10)
Target Lesion Failure (TLF) at 2 and 5 years
Same ARC-2 composite definition as primary endpoint, assessed at 2 and 5 years.
Measured: 2 years; 5 years
Cardiac death
Measured: 30 days; 12 months; 2 years; 5 years
Target vessel myocardial infarction
Myocardial infarction attributable to the target vessel, defined per ARC-2 and the 4th Universal Definition of Myocardial Infarction.
Measured: 30 days; 12 months; 2 years; 5 years
Clinically indicated target lesion revascularisation
Measured: 30 days; 12 months; 2 years; 5 years
Patient-oriented composite endpoint (POCE)
Composite of all-cause death, any myocardial infarction, and any revascularisation.
Measured: 12 months; 2 years; 5 years
Definite or probable stent thrombosis (ARC-2)
Measured: Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Target vessel failure (TVF)
Composite of cardiac death, target vessel myocardial infarction, and clinically indicated target vessel revascularisation.
Measured: 12 months; 2 years; 5 years
Major bleeding (BARC type 3 or 5)
Measured: 12 months; 2 years; 5 years
All-cause mortality
Measured: 12 months; 2 years; 5 years
Late lumen loss (mm)
In-stent late lumen loss by quantitative coronary angiography, assessed only in patients undergoing clinically indicated follow-up angiography.
Measured: At clinically indicated follow-up angiography, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Dorian Garin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dorian Garin, University Hospital, Geneva
- Investigators
- Juan F Iglesias, MD, FESC, FACC, Principal investigator, Geneva University Hospitals (HUG), Interventional Cardiology UnitDorian Garin, MD, Study director, Geneva University Hospitals (HUG), Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563231
- Sponsor's protocol ID
- POLARIS
- Other IDs
- POLARIS v1 04.03.2026
- Acronym
- POLARIS
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised individual participant data may be made available to other researchers upon reasonable written request addressed to the sponsor-investigator after publication of the primary 12-month results, subject to a data sharing agreement and approval by the competent ethics committee.
Publications
Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
PubMed 29891620Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
PubMed 21670242Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
PubMed 30165617
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POLARIS : POLymer-free Sirolimus Eluting Stent: Real-world Investigation of Safety and Outcomes
- ClinicalTrials.gov ID
- NCT07563231
- Acronym / sponsor ID
- POLARIS / POLARIS
- Conditions
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Stent Thrombosis, Percutaneous Coronary Intervention
- Keywords
- drug-eluting stent, polymer-free stent, sirolimus, percutaneous coronary intervention, target lesion failure, registry, real-world evidence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dorian GarinUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2036 (estimated)
- First posted
- 1 May 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.
POLARIS is a prospective, single-centre, single-arm observational pilot registry evaluating the real-world safety and efficacy of the Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) polymer-free sirolimus-eluting stent in consecutive adult patients undergoing percutaneous coronary intervention (PCI). The primary endpoint is target lesion failure (TLF) at 12 months, defined per Academic Research Consortium-2 (ARC-2) criteria as the device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. Patients treated since January 2021 will be retrospectively identified and prospectively consented, with follow-up through 5 years. The registry will provide the first Western clinical evidence on this CE-marked device and serve as a template for a future national Swiss multicentre registry.
Detailed description
BACKGROUND. Newer-generation drug-eluting stents (DES) remain associated with late stent-related adverse events at approximately 2% per year, driven by neoatherosclerosis, delayed endothelial healing, and chronic inflammation attributable to permanent polymer coatings. Polymer-free DES were developed to remove this substrate. The polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) (after: study device) is a novel polymer-free sirolimus-eluting stent built on a thin-strut (73 micrometres) cobalt-chromium platform, with drug delivery via biodegradable phospholipid submicron carriers (200-300 nm) confined to the abluminal surface, and a proprietary fusion coating extending sirolimus up to 5 mm beyond the stent edges. The device received CE marking on 24 January 2020. Only limited non-randomized Indian clinical data exist; no Western clinical data have been published.
OBJECTIVES. Primary: to evaluate device-oriented safety and efficacy (TLF at 12 months) of the stent in an all-comer population undergoing PCI at Geneva University Hospitals. Secondary: TLF at 2 and 5 years; individual components of TLF (cardiac death, target vessel MI, clinically indicated target lesion revascularisation) at 30 days, 12 months, 2 years, and 5 years; patient-oriented composite endpoint (all-cause death, any MI, any revascularisation); stent thrombosis (definite / probable, ARC-2, with temporal classification); target vessel failure; major bleeding (BARC 3 or 5); all-cause mortality; and late lumen loss when angiographic follow-up is available.
DESIGN. Prospective, single-centre, single-arm observational registry (Category A research with human subjects per the Swiss Human Research Act). Hybrid enrolment: retrospective identification from January 2021, prospective consent, and prospective follow-up at 30 days, 12 months, 2 years, and 5 years via medical records and telephone interview.
POPULATION. All consecutive adult patients (>= 18 years) treated with at least one study device stent at Geneva University Hospitals since January 2021, with an indication for PCI according to current European or American guidelines, able to provide written informed consent, and with sufficient knowledge of French, German, English, or Italian.
STATISTICS. Exploratory, descriptive analysis. Binary endpoints with Clopper-Pearson 95% confidence intervals; time-to-event analysis by Kaplan-Meier with Greenwood 95% CIs. Pre-specified exploratory subgroup analyses (sex, clinical presentation, diabetes, age, lesion complexity, stent length) presented as forest plots without between-group p-values. Sensitivity analyses include per-protocol, complete-case, landmark (30 days to 12 months), Fine-Gray competing-risk, and tipping point analyses. Analyses in Python (lifelines, pandas, scipy, statsmodels). Reporting follows STROBE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POLARIS cohort | – | Device: Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)Consecutive adult patients who received at least one polymer-free sirolimus-eluting stent during PCI at Geneva University Hospitals between January 2021 and December 2025. No study-mandated procedures; clinical care follows standard institutional practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients who underwent percutaneous coronary intervention with implantation of at least one ABLUMINUS NP sirolimus-eluting stent at Geneva University Hospitals between January 2021 and December 2025.
Key inclusion criteria (6 listed)
- Age >= 18 years at the time of the index procedure.
- Percutaneous coronary intervention performed at Geneva University Hospitals between January 2021 and December 2025.
- Implantation of at least one study device
- Indication for PCI according to current European or American guidelines.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Documented refusal to participate in research through opt-out from general consent.
- Inability to provide informed consent (cognitive impairment or other).
- Inability to be contacted for informed consent (no valid contact information, or unreachable after three contact attempts).
- Life expectancy less than 12 months due to non-cardiac comorbidities at the time of consent.
- Participation in another clinical trial that would interfere with the endpoints of this registry.
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 |
|---|---|---|
| Polymer-free sirolimus-based submicron carrier-eluting stent Focus np (Abluminus np, Concept Medical, Tampa, FL, USA)Thin-strut (73 micrometres) cobalt-chromium coronary stent with polymer-free submicron phospholipid carriers (200-300 nm) delivering sirolimus exclusively to the abluminal surface, and fusion coating extending sirolimus deposition up to 5 mm beyond the stent edges. CE-marked 24 January 2020. Available diameters 2.25-4.0 mm and lengths 8-40 mm. Manufactured by Concept Medical, Tampa, FL, USA. Implantation and peri-procedural care follow operator discretion and institutional standard of care. | Device | POLARIS cohort |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
Device-oriented composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation, defined per Academic Research Consortium-2 (ARC-2) criteria. Binary categorical variable analysed by time-to-first-event method.
10 secondary outcomes
Target Lesion Failure (TLF) at 2 and 5 years
Time frame: 2 years; 5 years
Cardiac death
Time frame: 30 days; 12 months; 2 years; 5 years
Target vessel myocardial infarction
Time frame: 30 days; 12 months; 2 years; 5 years
Clinically indicated target lesion revascularisation
Time frame: 30 days; 12 months; 2 years; 5 years
Patient-oriented composite endpoint (POCE)
Time frame: 12 months; 2 years; 5 years
Definite or probable stent thrombosis (ARC-2)
Time frame: Acute (0-24h), subacute (1-30d), late (30d-1y), very late (>1y), up to 5 years
Target vessel failure (TVF)
Time frame: 12 months; 2 years; 5 years
Major bleeding (BARC type 3 or 5)
Time frame: 12 months; 2 years; 5 years
All-cause mortality
Time frame: 12 months; 2 years; 5 years
Late lumen loss (mm)
Time frame: At clinically indicated follow-up angiography, up to 5 years
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 9 Jun 2026.
- Background: PubMed 29891620Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Background: PubMed 21670242Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- Background: PubMed 30165617Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; ESC Scientific Document Group. Fourth universal definition of myocardial infarction (2018). Eur Heart J. 2019 Jan 14;40(3):237-269. doi: 10.1093/eurheartj/ehy462. No abstract available.
- Individual participant dataSharing planned: Yes. Anonymised individual participant data may be made available to other researchers upon reasonable written request addressed to the sponsor-investigator after publication of the primary 12-month results, subject to a data sharing agreement and approval by the competent ethics committee.
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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.
Dorian Garin, MD contact
Juan F Iglesias, MD, FESC, FACC principal investigator
Geneva University Hospitals (HUG), Interventional Cardiology Unit
Dorian Garin, MD study director
Geneva University Hospitals (HUG), Department of Cardiology
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 and Acute Coronary Syndrome, run by Dorian Garin at 1 site in Switzerland.
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 6 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: opening soon, as of the sponsor's last update on 9 Jun 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 Switzerland. 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 Juan F Iglesias, MD, FESC, FACC (+41 22 372 72 00, juanFernando.Iglesias@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 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 NCT07563231, which also lists 3 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 9 Jun 2026.