Diabetes MellitusDUBSTENT-DMNCT07303439
Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus
A study testing Percutaneous Coronary Intervention in people with Diabetes Mellitus and Coronary Arterial Disease (CAD), run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
Purpose of this study: The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Coronary Arterial Disease (CAD), de Novo Coronary Lesions
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIreland
- Study dates
- 6 Aug 2025to 5 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute or chronic coronary syndrome
- Diagnosis of diabetes
- Patients undergoing PCI for de novo lesions in native coronary arteries
- Patients able and willing to provide written informed consent
- Age ≥ 18 years.
- Patients able and willing to comply with the study procedures and follow-up.
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- All angiographic inclusion criteria fulfilled:
- the lesion has been deemed treatable
- the guidewire has crossed the lesion
- the lesion has been successfully pre-dilated, where balloon expansion is complete, residual stenosis is less than 50% and thrombolysis in myocardial infarction (TIMI) flow is >2, and there is no evidence of flow-limiting dissection is seen.
Who cannot join
- Lesions located at the left main coronary artery.
- Patient presents with a ST-elevation myocardial infarction (STEMI).
- Patient with acute cardiac decompensation or acute cardiogenic shock.
- Patient with impaired renal function (glomerular filtration rate < 30 mL/min/1.73 m2).
- Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.
- Evidence of high-grade dissection (National Heart, Lung, and Blood Institute (NHLBI) class C or greater) at baseline
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- Known hypersensitivity or contraindication to sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast that cannot be pre-treated.
- Patients unable to take dual antiplatelet therapy for 6-12 months
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study.
- Subject currently enrolled in other investigational device or drug trial in which the primary endpoint has not yet been reached.
- Anticipated difficulties to complete the angiographic surveillance.
- Patient with a life expectancy of less than 12 months.
- Patients lacking mental capacity (i.e. patients suffering from dementia and others) to provide informed consent.
- The study will not recruit participants who, in the opinion of the investigator, do not have an adequate understanding of English. Only participants who can fully comprehend the implications of participating in the study will be recruited
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carmen Farrelly, BSc. contact
Ireland1 site, 1 recruiting
- Recruiting
Mater Private Hospital
Dublin, County Dublin, D07 KWR1
Amy Carswell, MSc, +353858802094, amy.carswell@materprivate.ie
Carmen Farrelly, BSc, +3538822673, carmen.farrelly@materprivate.ie
About this study
Purpose of this study:
The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.
Read more
The treatment being investigated:
In this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually:
- Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug.
- Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again.
Both drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coronary artery disease in Europe.
How will the study be carried out?
This study is being conducted in 4 hospitals across Ireland. We aim to recruit 120 participants s in this study. If you agree to participate in this study and sign the informed consent form, you will be asked to participate in the screening process, which will determine if you meet the conditions to participate in the study.
You will be "randomised" into one of the 3 study groups. Randomisation means that you are put into a group by chance (similarly to the roll of a dice). Neither you nor your doctor can choose the group you will be in. You will not know which group you were placed in until the end of the study. However, your doctor will know which study group you were placed in.
- 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only
- 40 patients will be treated with Orsiro® (Drug Eluting Stent) only
- 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent).
If you agree to participate in the study you will be invited to come back for a check-up angiogram 6 months after your procedure to make sure that the treatment has been a success. This is sometimes done in normal clinical practice, but it is not done routinely. You will not be charged for this additional test.
Read the detailed description
Study Rationale
Stent failure, ISR and TLF remain a significant challenge when considering percutaneous treatment options for de novo CAD in patients with diabetes mellitus. The use of combination treatment with both DCB and DES in this population has not been studied. This study aims to compare the safety and efficacy of a novel combination revascularisation strategy to DCB or DES alone in patients with de novo CAD and diabetes mellitus, a patient group that is at increased risk of TLF compared to patients who do not have diabetes mellitus.
Study Objective
To investigate the efficacy and safety of combination treatment for patients with diabetes mellitus and de novo obstructive CAD undergoing PCI consisting of angioplasty with DCB combined with DES in comparison to single device treatments with either DES or DCB alone, in a randomised, multicentric clinical trial.
Study Design
DUBSTENT-DIABETES is a prospective, randomized, multicentre, assessor-blind, investigator-initiated clinical trial. To investigate the safety and efficacy of combination treatment for patients with de novo CAD undergoing PCI. Consisting of angioplasty with DCB combined with stenting with DES in comparison to single device treatments with either DES or DCB alone.
The study will enrol 120 patients who will be randomized in a 1:1:1 fashion to receive Pantera® Lux® DCB in combination with Orsiro® DES (investigational strategy), or Pantera® Lux® DCB alone, or Orsiro® DES alone (standard of care arm). Subjects will be prospectively enrolled at 4 sites in the Republic of Ireland. In the Pantera® Lux® DCB alone comparator arm, bailout stenting will be allowed under certain criteria. The criteria for bailout stenting will be NHLBI dissection class D to F, and class C at the discretion of the operator. The Freesolveᵀᴹ resorbable magnesium scaffold should be used for bailout stenting to facilitate a leave nothing behind strategy for this comparator arm.
Patients will be screened according to the study inclusion and exclusion criteria (section) prior to coronary angiography. Patients with diabetes mellitus, planned for PCI for de novo obstructive CAD will be eligible. Baseline QCA will be performed to screen patients according to the angiographic inclusion criteria. Subjects who meet all of the study inclusion and exclusion criteria will be eligible for randomisation. Included subjects will then be randomised to either the investigational arm of combination treatment (DCB and DES treatment), or to the comparator arms of DCB treatment, or DES treatment (standard of care arm). Subjects will then receive treatment according to the randomisation.
All procedures will be performed by fully trained operators with several years of interventional experience. All procedures will be performed according to current guidelines and international standards using the Pantera® Lux® DCB and/or the Orsiro® DES. In all patients intravascular imaging is encouraged, but not mandated in the protocol. A pre-specified sub study will take place for 30 subjects who will receive optimal coherence tomography (OCT) imaging.
Baseline characteristics, vital signs, concomitant diseases, cardiovascular risk factors, medication, routine laboratory analyses, ECG data, QCA images and procedural data including periprocedural complications, and follow-up data will be collected.
All included subjects will undergo protocol mandated QCA at 6-months. The primary endpoint of the study, in-segment DS will be assessed by QCA at 6-months follow-up. Key secondary endpoints include TLF, the individual components of TLF (cardiovascular death, non-fatal MI related to the target vessel and unplanned ischaemia-driven TLR). Secondary endpoints will be assessed at 30 days, 6 months and annually up to 5 years. All angiographic endpoints including the primary endpoint will be analysed at Imaging Core Laboratory CVRI Dublin. All clinical events will be adjudicated upon by an independent CEC. The study will be conducted in accordance with the investigation plan, the current version of the Declaration of Helsinki, and national legal and regulatory requirements (2013) (15).
Study Duration
This study will enrol 120 patients in up to 4 investigative centres in the Republic of Ireland over a period of 12 months. Subjects will have follow up QCA performed 6 months after the index QCA. In-person or telephone follow-up appointments will take place at 1 year, then annually up to 5 years after the index procedure. The expected duration of the study is approximately 78 months. This consists of 12 months enrolment followed by 5 years follow up of participants from the time of enrolment of the final participant. An additional 6 months will be permitted for data freeze and statistical analysis.
- Conditions
- Diabetes Mellitus, Coronary Arterial Disease (CAD), de Novo Coronary Lesions, De Novo Stenosis
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- Diabetes Mellitus, Coronary Artery Disease, Drug-coated Balloon, Drug-Eluting Stent, Target Vessel Failure
- Medical subject headings
- Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Also called PTCA
Percutaneous transluminal coronary angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon in combination with drug-eluting stent | Experimental | 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent). Receives: Procedure: Percutaneous Coronary Intervention |
| Drug-coated balloon only | Experimental | 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only Receives: Procedure: Percutaneous Coronary Intervention |
| Drug-eluting stent only | Active comparator | 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent). Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Diameter Stenosis
The primary endpoint is percentage diameter stenosis (%DS) of the target lesion segment (target lesion ± 5 mm either side) assessed by QCA at 6 months.
Measured: 6 months post PCI (treatment)
Secondary outcomes (2)
Late Lumen Loss
Late lumen loss assessed by Quantitative Coronary Angiogram (QCA)
Measured: 6 months
Binary Restenosis
Binary Restenosis assessed by Quantitative Coronary Angiogram (QCA)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start6 Aug 2025
- Primary completion16 Dec 2026 (estimated)
- Study completion5 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Factorial
- Model description
- Patient's will be randomised to one of three arms, which include: 1. . Drug-coated balloon in combination with Drug-eluting Stent 2. . Drug-coated balloon only 3. . Drug-eluting stent only
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiovascular Research Institute Dublin
- Responsible party
- Sponsor
- Investigators
- Robert A Byrne, PhD, Study chair, RCSI University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303439
- Sponsor's protocol ID
- 25183A001
- Acronym
- DUBSTENT-DM
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Dual Device Treatment Involving Drug-coated Balloon Angioplasty and Drug-eluting Stent Implantation Compared to Single Device Treatments in Patients With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07303439
- Acronym / sponsor ID
- DUBSTENT-DM / 25183A001
- Conditions
- Diabetes Mellitus, Coronary Arterial Disease (CAD), de Novo Coronary Lesions, De Novo Stenosis
- Keywords
- Diabetes Mellitus, Coronary Artery Disease, Drug-coated Balloon, Drug-Eluting Stent, Target Vessel Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Cardiovascular Research Institute Dublin
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 5 Aug 2031 (estimated)
- First posted
- 24 Dec 2025 (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.
Purpose of this study:
The purpose of the study is to find out whether using a drug coated balloon in combination with a drug-eluting stent is better than the standard practice of using either device on its own. This study is specifically looking at patients with diabetes who have coronary artery disease. This means that their arteries become restricted or blocked, and these restrictions or blockages are called lesions. The study will look at diabetic patients undergoing treatment for lesions in segments of their coronary arteries that have not previously been treated with stents. These are called 'de novo' lesions.
The treatment being investigated:
In this study, we are comparing two devices, either used together or on their own to treat coronary artery disease. These devices are commercially available in Europe and carry the mark. This study is being carried out to compare the effectiveness of combining the two devices or using them individually:
- Pantera® Lux® Paclitaxel Drug Coated Balloon, abbreviated Pantera® Lux® (DCB) A drug coated balloon is a balloon which is covered by an anti-proliferative drug.
- Orsiro® biodegradable polymer Sirolimus Eluting Stent Orsiro® (DES) A stent is a short, wire mesh tube that acts like a scaffold to keep your artery open. A drug eluting stent is coated with medication that reduces the risk of the artery becoming blocked again.
Both drug-eluting stents and drug-coated balloons are used routinely for the treatment of 'de novo' coronary artery disease in Europe.
How will the study be carried out?
This study is being conducted in 4 hospitals across Ireland. We aim to recruit 120 participants s in this study. If you agree to participate in this study and sign the informed consent form, you will be asked to participate in the screening process, which will determine if you meet the conditions to participate in the study.
You will be "randomised" into one of the 3 study groups. Randomisation means that you are put into a group by chance (similarly to the roll of a dice). Neither you nor your doctor can choose the group you will be in. You will not know which group you were placed in until the end of the study. However, your doctor will know which study group you were placed in.
- 40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only
- 40 patients will be treated with Orsiro® (Drug Eluting Stent) only
- 40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent).
If you agree to participate in the study you will be invited to come back for a check-up angiogram 6 months after your procedure to make sure that the treatment has been a success. This is sometimes done in normal clinical practice, but it is not done routinely. You will not be charged for this additional test.
Detailed description
Study Rationale
Stent failure, ISR and TLF remain a significant challenge when considering percutaneous treatment options for de novo CAD in patients with diabetes mellitus. The use of combination treatment with both DCB and DES in this population has not been studied. This study aims to compare the safety and efficacy of a novel combination revascularisation strategy to DCB or DES alone in patients with de novo CAD and diabetes mellitus, a patient group that is at increased risk of TLF compared to patients who do not have diabetes mellitus.
Study Objective
To investigate the efficacy and safety of combination treatment for patients with diabetes mellitus and de novo obstructive CAD undergoing PCI consisting of angioplasty with DCB combined with DES in comparison to single device treatments with either DES or DCB alone, in a randomised, multicentric clinical trial.
Study Design
DUBSTENT-DIABETES is a prospective, randomized, multicentre, assessor-blind, investigator-initiated clinical trial. To investigate the safety and efficacy of combination treatment for patients with de novo CAD undergoing PCI. Consisting of angioplasty with DCB combined with stenting with DES in comparison to single device treatments with either DES or DCB alone.
The study will enrol 120 patients who will be randomized in a 1:1:1 fashion to receive Pantera® Lux® DCB in combination with Orsiro® DES (investigational strategy), or Pantera® Lux® DCB alone, or Orsiro® DES alone (standard of care arm). Subjects will be prospectively enrolled at 4 sites in the Republic of Ireland. In the Pantera® Lux® DCB alone comparator arm, bailout stenting will be allowed under certain criteria. The criteria for bailout stenting will be NHLBI dissection class D to F, and class C at the discretion of the operator. The Freesolveᵀᴹ resorbable magnesium scaffold should be used for bailout stenting to facilitate a leave nothing behind strategy for this comparator arm.
Patients will be screened according to the study inclusion and exclusion criteria (section) prior to coronary angiography. Patients with diabetes mellitus, planned for PCI for de novo obstructive CAD will be eligible. Baseline QCA will be performed to screen patients according to the angiographic inclusion criteria. Subjects who meet all of the study inclusion and exclusion criteria will be eligible for randomisation. Included subjects will then be randomised to either the investigational arm of combination treatment (DCB and DES treatment), or to the comparator arms of DCB treatment, or DES treatment (standard of care arm). Subjects will then receive treatment according to the randomisation.
All procedures will be performed by fully trained operators with several years of interventional experience. All procedures will be performed according to current guidelines and international standards using the Pantera® Lux® DCB and/or the Orsiro® DES. In all patients intravascular imaging is encouraged, but not mandated in the protocol. A pre-specified sub study will take place for 30 subjects who will receive optimal coherence tomography (OCT) imaging.
Baseline characteristics, vital signs, concomitant diseases, cardiovascular risk factors, medication, routine laboratory analyses, ECG data, QCA images and procedural data including periprocedural complications, and follow-up data will be collected.
All included subjects will undergo protocol mandated QCA at 6-months. The primary endpoint of the study, in-segment DS will be assessed by QCA at 6-months follow-up. Key secondary endpoints include TLF, the individual components of TLF (cardiovascular death, non-fatal MI related to the target vessel and unplanned ischaemia-driven TLR). Secondary endpoints will be assessed at 30 days, 6 months and annually up to 5 years. All angiographic endpoints including the primary endpoint will be analysed at Imaging Core Laboratory CVRI Dublin. All clinical events will be adjudicated upon by an independent CEC. The study will be conducted in accordance with the investigation plan, the current version of the Declaration of Helsinki, and national legal and regulatory requirements (2013) (15).
Study Duration
This study will enrol 120 patients in up to 4 investigative centres in the Republic of Ireland over a period of 12 months. Subjects will have follow up QCA performed 6 months after the index QCA. In-person or telephone follow-up appointments will take place at 1 year, then annually up to 5 years after the index procedure. The expected duration of the study is approximately 78 months. This consists of 12 months enrolment followed by 5 years follow up of participants from the time of enrolment of the final participant. An additional 6 months will be permitted for data freeze and statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patient's will be randomised to one of three arms, which include: 1. . Drug-coated balloon in combination with Drug-eluting Stent 2. . Drug-coated balloon only 3. . Drug-eluting stent only
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon in combination with drug-eluting stent | Experimental | Procedure: Percutaneous Coronary Intervention40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent). |
| Drug-coated balloon only | Experimental | Procedure: Percutaneous Coronary Intervention40 patients will be treated with Pantera® Lux® (Drug Coated Balloon) only |
| Drug-eluting stent only | Active comparator | Procedure: Percutaneous Coronary Intervention40 patients will be treated with a combination of both Pantera® Lux® (Drug Coated Balloon) and Orsiro® (Drug Eluting Stent). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with acute or chronic coronary syndrome
- Diagnosis of diabetes
- Patients undergoing PCI for de novo lesions in native coronary arteries
- Patients able and willing to provide written informed consent
- Age ≥ 18 years.
Key exclusion criteria (14 listed)
- Lesions located at the left main coronary artery.
- Patient presents with a ST-elevation myocardial infarction (STEMI).
- Patient with acute cardiac decompensation or acute cardiogenic shock.
- Patient with impaired renal function (glomerular filtration rate < 30 mL/min/1.73 m2).
- Severe in-stent calcification that prevents a sufficient expansion of the DCB, unless adequately pre-treated, e.g. with super (high) pressure balloon, rotablation or lithotripsy.
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 |
|---|---|---|
| Percutaneous Coronary InterventionAlso: PTCAPercutaneous transluminal coronary angioplasty | Procedure or surgery | Drug-coated balloon in combination with drug-eluting stent, Drug-coated balloon only, Drug-eluting stent only |
Primary outcome
Percentage Diameter Stenosis
Time frame: 6 months post PCI (treatment)
The primary endpoint is percentage diameter stenosis (%DS) of the target lesion segment (target lesion ± 5 mm either side) assessed by QCA at 6 months.
2 secondary outcomes
Late Lumen Loss
Time frame: 6 months
Binary Restenosis
Time frame: 6 months
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 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Carmen Farrelly, BSc. contact
Robert A Byrne, PhD study chair
RCSI University of Medicine and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Diabetes Mellitus and Coronary Arterial Disease (CAD), run by Royal College of Surgeons, Ireland at 1 site in Ireland.
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 10 inclusion and 14 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 24 Dec 2025. 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 Ireland. 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 Amy Carswell, MSc. (+353 (0) 85 880 2094, amy.carswell@materprivate.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Diameter Stenosis (time frame: 6 months post PCI (treatment)). 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 24 Dec 2025.