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
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.
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- 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.
- 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
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- 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