Coronary artery disease Narrowed heart arteries
Conditions
Interventions
Serial FFR-CT measurement.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 (Subject belonging to a vulnerable population (per investigator’s judgment, e.g., subordinate hospital staff) or is unable to read or write).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in non-invasive FFR-CT between post-procedure and 12-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| LLL and change in MLA and PB in the target lesion measured on CCTA between post-procedure and at 12-month follow-up;Association between (change in) LLL/MLA/PB and (change in) non-invasive FFR-CT; MACE, TLR, and BARC-3 or 5 bleeding (according to the Bleeding ARC (22)) at 12-month of follow-up. | — |
Countries
Netherlands
Contacts
Public ContactBEPM Claessen
Amsterdam UMC
Outcome results
None listed