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NCT Number: NCT07811960

Non-Invasive Follow-Up of Patients With Coronary Artery Disease Treated With Drug-Coated Balloon PCI Using CT-Derived Fractional Flow Reserve

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.

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Key information

Conditions

Coronary Arterial Disease (CAD) Acute Coronary Syndrome Acute Coronary Syndromes (ACS) Cardiovascular Diseases Heart Diseases Myocardial Ischemia Stable Coronary Artery Disease Undergoing PCI Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • Presence of a de novo lesion;
  • Successful DCB-PCI of a native coronary artery or major side branch.

Exclusion criteria

  • 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.
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Late lumen loss (LLL)

    Time frame: From baseline to 9 month follow-up.

    Late lumen loss (LLL) in mm in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.

  2. Change in Minimal Lumen Area (MLA)

    Time frame: From baseline to 9 month follow-up.

    Change in Minimal Lumen Area (MLA) in mm² in the target lesion measured on CCTA between post-procedure and at 9-month follow-up.

  3. Change in Plaque Burden (PB)

    Time frame: From baseline to 9 month follow-up.

    Change in Percent Plaque Burden (PB) in the target lesion measured on CCTA be tween post-procedure and at 9-month follow-up.

  4. Clinical outcomes

    Time frame: From baseline to 5 years follow-up.

    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.

  5. Correlations between CCTA-derived measurements

    Time frame: From baseline to 9 month follow-up.

    Correlation between (change in) LLL/MLA/PB and (change in) non-invasive CT-μFR.

Study contacts

Contact information is provided by the study sponsor or research team.

Inge T Bosch

CONTACT

[email protected]

+31 20 566 6603

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

Registry of Coronary Disease Outcomes Revascularizing With Drug-Coated Balloons Computed-Tomography Fractional Flow Reserve Sub-Study

Acronym: RECORD-CT-FFR

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Sep 10, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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