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NCT07811960Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
19 Aug 2026
Start date
Sept 2026
Primary completion date
Sept 2029
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT07811960

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From Sept 2026 to the primary completion date, Sept 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous CABG;
  • Metallic implants in or around the target vessel;

Other illness

  • Presence of a comorbid condition with a life expectancy of less than one year;

Lab values

  • 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.

Other

  • No Protégé DCB was used;
  • Pregnancy or pregnancy status unknown;
  • Inability to provide informed consent

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.