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

NCT07811960 | Not Yet Recruiting DMC

• 1 other identifier: NL-011531
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to 9 month follow-up.

Secondary Outcomes (5)

• Late lumen loss (LLL)

  From baseline to 9 month follow-up.

• Change in Minimal Lumen Area (MLA)

  From baseline to 9 month follow-up.

• Change in Plaque Burden (PB)

  From baseline to 9 month follow-up.

• Clinical outcomes

  From baseline to 5 years follow-up.

• Correlations between CCTA-derived measurements

  From baseline to 9 month follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Inge T Bosch

CONTACT

+31 20 566 6603; i.t.bosch@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist, Department of Cardiology

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: September 10, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2033
• Last Updated: September 16, 2026

Record last verified: 2026-08