Coronary Arterial Disease (CAD)RECORD-CT-FFRNCT07811960
Non-Invasive Follow-Up of Patients With Coronary Artery Disease Treated With Drug-Coated Balloon PCI Using CT-Derived Fractional Flow Reserve
An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndromes (ACS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Trial summary
This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Acute Coronary Syndromes (ACS), Stable Coronary Artery Disease Undergoing PCI
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2033
- 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 patients aged 18 years or older scheduled for PCI of a native coronary artery will be screened for inclusion in the trial. Patients will be included at the Amsterdam UMC.
Who may be able to join
- Age ≥ 18 years;
- Presence of a de novo lesion;
- Successful DCB-PCI of a native coronary artery or major side branch.
Who cannot join
- No Protégé DCB was used;
- Previous CABG;
- Ineligibility for CCTA acquisition due to:
- Known renal insufficiency, i.e. eGFR ≤ 30 mL/min/1.73m²;
- Known hypersensitivity or contraindication to CT contrast agents;
- Body weight > 150 kg.
Show all 10Show fewer
- Metallic implants in or around the target vessel;
- Pregnancy or pregnancy status unknown;
- Presence of a comorbid condition with a life expectancy of less than one year;
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study
This study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).
Participants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.
The primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.
- Conditions
- Coronary Arterial Disease (CAD), Acute Coronary Syndromes (ACS), Stable Coronary Artery Disease Undergoing PCI
- Keywords
- drug coated balloon, Non-invasive follow-up, Coronary Computed Tomography Angiography (CCTA), CT-derived FFR
- Medical subject headings
- Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in CT-μFR
The change in non-invasive CT-μFR between post-procedure and 9-month follow-up within the treated coronary segment treated with DCB.
Measured: From baseline to 9 month follow-up.
Secondary outcomes (5)
Late lumen loss (LLL)
Late lumen loss (LLL) in mm in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.
Measured: From baseline to 9 month follow-up.
Change in Minimal Lumen Area (MLA)
Change in Minimal Lumen Area (MLA) in mm² in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.
Measured: From baseline to 9 month follow-up.
Change in Plaque Burden (PB)
Change in Percent Plaque Burden (PB) in the target lesion measured on CCTA be tween post-procedure and at 9-month follow-up.
Measured: From baseline to 9 month follow-up.
Clinical outcomes
MACE, TLR, and BARC-3 or 5 bleeding (according to the Bleeding ARC) at 1-month, 1-year, 3-years and 5-years follow-up.
Measured: From baseline to 5 years follow-up.
Correlations between CCTA-derived measurements
Correlation between (change in) LLL/MLA/PB and (change in) non-invasive CT-μFR.
Measured: From baseline to 9 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)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
- 150 participants (estimated)
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
- NCT07811960
- Sponsor's protocol ID
- NL-011531
- Acronym
- RECORD-CT-FFR
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study
- ClinicalTrials.gov ID
- NCT07811960
- Acronym / sponsor ID
- RECORD-CT-FFR / NL-011531
- Conditions
- Coronary Arterial Disease (CAD), Acute Coronary Syndromes (ACS), Stable Coronary Artery Disease Undergoing PCI
- Keywords
- drug coated balloon, Non-invasive follow-up, Coronary Computed Tomography Angiography (CCTA), CT-derived FFR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 10 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 study investigates changes in coronary artery anatomy and physiology after treatment with a paclitaxel drug-coated balloon (DCB) during percutaneous coronary intervention (PCI). Unlike conventional stenting, DCB treatment delivers an antiproliferative drug to the vessel wall without leaving a permanent metallic implant. The absence of a permanent implant allows non-invasive assessment of the treated coronary artery during follow-up using coronary CT angiography (CCTA).
Participants will undergo two CCTA examinations: an early scan within two weeks after PCI and a follow-up scan after nine months. CT-derived fractional flow reserve (CT-μFR) will be calculated from both scans to assess changes in μFR of the treated coronary artery over time. CCTA will also be used to evaluate changes in coronary plaque and vessel characteristics.
The primary objective is to determine whether CT-μFR changes between early and nine-month follow-up after DCB-PCI. Secondary objectives include evaluating changes in plaque and vessel characteristics on CCTA and assessing clinical outcomes during follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients aged 18 years or older scheduled for PCI of a native coronary artery will be screened for inclusion in the trial. Patients will be included at the Amsterdam UMC.
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Presence of a de novo lesion;
- Successful DCB-PCI of a native coronary artery or major side branch.
Key exclusion criteria (10 listed)
- No Protégé DCB was used;
- Previous CABG;
- Ineligibility for CCTA acquisition due to:
- Metallic implants in or around the target vessel;
- Pregnancy or pregnancy status unknown;
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
Difference in CT-μFR
Time frame: From baseline to 9 month follow-up.
The change in non-invasive CT-μFR between post-procedure and 9-month follow-up within the treated coronary segment treated with DCB.
5 secondary outcomes
Late lumen loss (LLL)
Time frame: From baseline to 9 month follow-up.
Change in Minimal Lumen Area (MLA)
Time frame: From baseline to 9 month follow-up.
Change in Plaque Burden (PB)
Time frame: From baseline to 9 month follow-up.
Clinical outcomes
Time frame: From baseline to 5 years follow-up.
Correlations between CCTA-derived measurements
Time frame: From baseline to 9 month follow-up.
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 16 Sep 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and Acute Coronary Syndromes (ACS), run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
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 3 inclusion and 10 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 16 Sep 2026. 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 Inge T Bosch (+31 20 566 6603, 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?
Difference in CT-μFR (time frame: From baseline to 9 month 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 16 Sep 2026.