Acute Coronary Syndromes (ACS), Coronary Arterial Disease (CAD), Stable Coronary Artery Disease Undergoing PCI
Conditions
Keywords
drug coated balloon, Non-invasive follow-up, Coronary Computed Tomography Angiography (CCTA), CT-derived FFR
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.
Interventions
None listed
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in CT-μFR | 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
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss (LLL) | 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. |
| Change in Minimal Lumen Area (MLA) | 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. |
| Change in Plaque Burden (PB) | 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. |
| Clinical outcomes | 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. |
| Correlations between CCTA-derived measurements | From baseline to 9 month follow-up. | Correlation between (change in) LLL/MLA/PB and (change in) non-invasive CT-μFR. |
Contacts
CONTACTInge T Bosch
Outcome results
None listed