Percutaneous Coronary Intervention (PCI)RECORD-DCBNCT07231835
Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
An observational study of Percutaneous Coronary Intervention (PCI) and Drug Coated Balloon, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Drug Coated Balloon, Paclitaxel
- How many people
- 3,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2025to 30 Sep 2034
- 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: Adults (>18 years) with stable CAD or ACS who have a PCI indication and are treated with the Protégé DCB.
Who may be able to join
- Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
- Age ≥ 18 years
- Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
- Reference vessel diameter between 2.0 - 4.5 mm
- Patient suitable for dual antiplatelet therapy (DAPT)
Who cannot join
- Inability to provide informed consent
- Allergy to paclitaxel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Inge T Bosch, +31205663884, i.t.bosch@amsterdamumc.nl
About this study
Official title: RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.
- Conditions
- Percutaneous Coronary Intervention (PCI), Drug Coated Balloon, Paclitaxel, CAD - Coronary Artery Disease, ACS (Acute Coronary Syndrome), Stable Coronary Artery Disease (CAD), Myocardial Infarction
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
TLF at 1 year
Target Lesion Failure (TLF) at 1 year, defined as a composite of:
- Cardiovascular death
- Target vessel myocardial infarction (TV-MI)
- Clinically driven target lesion revascularization (TLR)
Measured: From enrollment to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start11 Nov 2025
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- 3,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bimmer Claessen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231835
- Sponsor's protocol ID
- 2025.0981
- Acronym
- RECORD-DCB
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RECORD-DCB: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons
- ClinicalTrials.gov ID
- NCT07231835
- Acronym / sponsor ID
- RECORD-DCB / 2025.0981
- Conditions
- Percutaneous Coronary Intervention (PCI), Drug Coated Balloon, Paclitaxel, CAD - Coronary Artery Disease, ACS (Acute Coronary Syndrome), Stable Coronary Artery Disease (CAD), Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 17 Nov 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.
The primary aim of this registry is to systematically collect and analyze real-world data on all patients undergoing PCI with the Protégé paclitaxel-eluting DCB to evaluate procedural outcomes, long-term efficacy, and safety across various clinical indications. This registry aims to assess the clinical effectiveness of DCB therapy across diverse patient populations, including those with stable coronary artery disease (CAD) and acute coronary syndromes (ACS), as well as various lesion subsets, encompassing (but not limited to) in-stent restenosis (ISR), de novo coronary lesions, small vessel disease, bifurcation and calcified lesions, coronary bypass graft lesions, and patients at high risk of bleeding. Additionally, the study aims to identify predictors of success, complications, and optimal treatment strategies to further refine the use of DCBs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (>18 years) with stable CAD or ACS who have a PCI indication and are treated with the Protégé DCB.
Key inclusion criteria (5 listed)
- Patients undergoing PCI with the Protégé paclitaxel-eluting DCB
- Age ≥ 18 years
- Presence of a de novo lesion or in-stent restenosis in a native coronary artery or a in a bypass graft and suitable for PCI
- Reference vessel diameter between 2.0 - 4.5 mm
- Patient suitable for dual antiplatelet therapy (DAPT)
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Allergy to paclitaxel
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
TLF at 1 year
Time frame: From enrollment to 1 year follow-up
Target Lesion Failure (TLF) at 1 year, defined as a composite of: * Cardiovascular death * Target vessel myocardial infarction (TV-MI) * Clinically driven target lesion revascularization (TLR)
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 17 Nov 2025.
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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.
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 Percutaneous Coronary Intervention (PCI) and Drug Coated Balloon, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 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 17 Nov 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 Netherlands. 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 Inge T Bosch (+31205663884, i.t.bosch@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF at 1 year (time frame: From enrollment to 1 year follow-up). 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 17 Nov 2025.