CAD - Coronary Artery DiseaseREPEATNCT06899555
REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients
An observational study of CAD - Coronary Artery Disease, run by Craigavon Area Hospital.
Trial summary
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CAD - Coronary Artery Disease
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2025to May 2027
- How long will I take part?
- 1 Year
- 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: A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Who may be able to join
- Age ≥ 18 years
- Patients with symptomatic coronary artery disease (including those with acute coronary syndromes or Chronic Coronary Syndromes) with either symptoms and/or ischaemia.
- The patient must be able to understand and provide informed consent and comply with all study procedures.
- Coronary angiographic inclusion criteria:
- ≥70% target lesion stenosis in LAD, LCX or RCA (or branches) which after successful pre-dilatation* has a residual stenosis ≤ 30% and no dissection of Type C or greater than (NHLBI guidelines)
- pre-dilation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, or laser
- Target vessel reference diameter between 2.0 and 4.5 mm.
Who cannot join
- Left ventricular ejection fraction (LVEF) ≤ 30%
- Acute ST elevation MI (STEMI)
- Cardiogenic shock within 2 days prior to the index PCI.
- Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs
- Allergy to imaging contrast media which cannot be adequately pre-medicated.
- Patient undergoing planned surgery within 3 months with the necessity to stop dual antiplatelet therapy (DAPT).
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- Patient is pregnant or breast feeding.
- Patient has received a heart transplant.
- Patient is unwilling or unable to give follow-up until study completion.
- Patient is currently participating in another trial.
- Life expectancy <1 year.
- Angiographic exclusion criteria:
- Target lesion in the left main coronary artery.
- Flow limiting target vessel thrombus
- Vessel dissection requiring bailout stenting.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dr Ian Brian Alexander Menown, MD(QUB), MB BCh BAO(QUB), MRCP contact
About this study
Official title: REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients (REPEAT Registry)
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.
Rational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting
Read more
A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Study Population - 500 Patients
Read the detailed description
Percutaneous coronary intervention (PCI) is a minimally invasive procedure treated as first line of treatment for symptomatic coronary artery disease (CAD). In 1977, Gruentzig performed the first balloon percutaneous transluminal coronary angioplasty (PTCA) but this was associated with acute dissection or elastic recoil and later restenosis (re-narrowing). Bare metal stents (BMS) were developed which helped address acute dissection or recoil but only modestly decreased the risk of restenosis (which still occurred in around 25% of people within six months).
Drug eluting stents (DES), coated with polymers which released drugs such as sirolimus or paclitaxel were then developed to reduce restenosis. Second-generation DES incorporating new metal platforms (changing from stainless steel to thinner strut metal alloys such as cobalt-chromium or platinum-chromium), new more biocompatible polymers, and new drugs such as Zotarolimus, Everolimus and Novolimus were associated with reduction in myocardial infarction (MI), target lesion revascularisation (TLR) and stent thombosis compared with first-generation DES.
However, even with second-generation DES, concerns remain regarding the risk of delayed healing, late stent thrombosis and in-stent restenosis (around 2% per year) and alteration of vascular physiology due to permanent caging by the stent. Hence, drug-eluting balloons (DEB), {also referred as Drug Coated Balloons (DCB)} were developed as a non-stent approach to circumvent some drawbacks of DES. Provided pre-dilatation does not induce excessive dissection or recoil requiring a stent, DEBs deliver rapid release and deposition of anti-restenotic drug in the vessel wall at the time of balloon inflation but without a permanent implant, thus enabling more rapid healing of the vessel, similar reduction in restenosis to DES but potentially reduced late complications.
Currently, DEBs are used in treating In-stent restenosis (ISR), bifurcation lesions, Ostial lesions, long \& large lesions, De novo of small vessel disease, complex coronary interventions, and high bleeding risk situations. Although DEBs are generally safe and non-inferior to other contemporary treatment procedure there are many unanswered questions about DEB technology in real world population. Geographical distribution of clinical trials or sample size and diversification is an important criterion to evaluate the safety and efficacy of the DEBs in real- world settings. The trend indicates fewer domestic trials for DEB. In lieu of the above clinical and translational gaps a registry is planned to assess safety and performance of the Drug Eluting Balloon in CAD patients.
- Conditions
- CAD - Coronary Artery Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, 500 Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion failure
Target Lesion failure through 12-months [composite of cardiac death, target vessel myocardial infarction (MI) and ischaemia-driven target lesion revascularization (TLR)]
Measured: 12 Month
Secondary outcomes (1)
Major Adverse Cardiac Event (MACE)
Major Adverse Cardiac Event (MACE) [Time Frame: through 12 Months] - Composite of all cause death, any MI, any revascularization
Device success [Time Frame: During index procedure] - Defined as the ability of the study device to be delivered, dilated and retrieved from the target lesion.
Procedural success [Time Frame: From Index procedure till discharge] - Defined as technical and angiographic success in the absence of Major Adverse Cardiac Events (MACE) during hospitalization.
Measured: MACE at 1 year; Procedural & Device Success at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Craigavon Area Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr I. B. A. Menown, Craigavon Area Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899555
- Sponsor's protocol ID
- TL/PMS/DEB/2024-01
- Acronym
- REPEAT
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 28 Mar 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 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry of Paclitaxel Coated Drug Eluting Balloon in All Comers PaTients (REPEAT Registry)
- ClinicalTrials.gov ID
- NCT06899555
- Acronym / sponsor ID
- REPEAT / TL/PMS/DEB/2024-01
- Conditions
- CAD - Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Craigavon Area HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Mar 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.
A post marketing, observational , multi centre, prospective registry to assess safety and performance of the Drug Eluting Balloon in patients undergoing percutaneous coronary intervention.
Rational : Although DEBs are generally considered safe, there remain many unanswered questions about DEB technology in a real-world population and only limited trial data from geographically or clinically diverse patient subgroups. To address some of the clinical and translational gaps in knowledge we thus plan a clinical registry to assess safety and performance of a novel design of a drug eluting
A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Study Population - 500 Patients
Detailed description
Percutaneous coronary intervention (PCI) is a minimally invasive procedure treated as first line of treatment for symptomatic coronary artery disease (CAD). In 1977, Gruentzig performed the first balloon percutaneous transluminal coronary angioplasty (PTCA) but this was associated with acute dissection or elastic recoil and later restenosis (re-narrowing). Bare metal stents (BMS) were developed which helped address acute dissection or recoil but only modestly decreased the risk of restenosis (which still occurred in around 25% of people within six months).
Drug eluting stents (DES), coated with polymers which released drugs such as sirolimus or paclitaxel were then developed to reduce restenosis. Second-generation DES incorporating new metal platforms (changing from stainless steel to thinner strut metal alloys such as cobalt-chromium or platinum-chromium), new more biocompatible polymers, and new drugs such as Zotarolimus, Everolimus and Novolimus were associated with reduction in myocardial infarction (MI), target lesion revascularisation (TLR) and stent thombosis compared with first-generation DES.
However, even with second-generation DES, concerns remain regarding the risk of delayed healing, late stent thrombosis and in-stent restenosis (around 2% per year) and alteration of vascular physiology due to permanent caging by the stent. Hence, drug-eluting balloons (DEB), {also referred as Drug Coated Balloons (DCB)} were developed as a non-stent approach to circumvent some drawbacks of DES. Provided pre-dilatation does not induce excessive dissection or recoil requiring a stent, DEBs deliver rapid release and deposition of anti-restenotic drug in the vessel wall at the time of balloon inflation but without a permanent implant, thus enabling more rapid healing of the vessel, similar reduction in restenosis to DES but potentially reduced late complications.
Currently, DEBs are used in treating In-stent restenosis (ISR), bifurcation lesions, Ostial lesions, long \& large lesions, De novo of small vessel disease, complex coronary interventions, and high bleeding risk situations. Although DEBs are generally safe and non-inferior to other contemporary treatment procedure there are many unanswered questions about DEB technology in real world population. Geographical distribution of clinical trials or sample size and diversification is an important criterion to evaluate the safety and efficacy of the DEBs in real- world settings. The trend indicates fewer domestic trials for DEB. In lieu of the above clinical and translational gaps a registry is planned to assess safety and performance of the Drug Eluting Balloon in CAD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, 500 Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A real-world, all-comers coronary artery disease (CAD) population undergoing percutaneous coronary intervention (PCI) and suitable for treatment with a Paclitaxel Coated Coronary Balloon Dilatation Catheter.
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patients with symptomatic coronary artery disease (including those with acute coronary syndromes or Chronic Coronary Syndromes) with either symptoms and/or ischaemia.
- The patient must be able to understand and provide informed consent and comply with all study procedures.
- ≥70% target lesion stenosis in LAD, LCX or RCA (or branches) which after successful pre-dilatation* has a residual stenosis ≤ 30% and no dissection of Type C or greater than (NHLBI guidelines)
- pre-dilation permitted with SC or NC balloon catheter, cutting/scoring balloon, rotational/orbital atherectomy, or laser
Key exclusion criteria (15 listed)
- Left ventricular ejection fraction (LVEF) ≤ 30%
- Acute ST elevation MI (STEMI)
- Cardiogenic shock within 2 days prior to the index PCI.
- Known contraindication or hypersensitivity to paclitaxel, and/or to any anti-thrombotic and anti-platelet class of drugs
- Allergy to imaging contrast media which cannot be adequately pre-medicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Lesion failure
Time frame: 12 Month
Target Lesion failure through 12-months [composite of cardiac death, target vessel myocardial infarction (MI) and ischaemia-driven target lesion revascularization (TLR)]
1 secondary outcome
Major Adverse Cardiac Event (MACE)
Time frame: MACE at 1 year; Procedural & Device Success at Baseline
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 28 Mar 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.
Dr Ian Brian Alexander Menown, MD(QUB), MB BCh BAO(QUB), MRCP contact
Questions about this trial
What is this clinical trial studying?
An observational study of CAD - Coronary Artery Disease, run by Craigavon Area Hospital.
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 7 inclusion and 15 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Dr Ian Brian Alexander Menown, MD(QUB), MB BCh BAO(QUB), MRCP (+ 44 2838 334444, ian.menown@southerntrust.hscni.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion failure (time frame: 12 Month). 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 28 Mar 2025.