arteriosclerosis coronary artery disease
Conditions
Interventions
After inclusion, patients will be randomized (1:1) to additional DCB treatment
or stenting of residual disease.
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 18 years • Clinical indication for revascularization of the CTO as determined by the local heart team (based on symptoms, documented ischemia, and viability) • Successful recanalization of the CTO with residual disease adjacent to the initial lesion
Exclusion criteria
Exclusion criteria: • Dissection affecting the flow (TIMI score 30%) or coronary perforation after predilation • Reference diameter of the vessel is 4.0 mm • Bifurcation lesion requiring the stenting of the side branch • Left main lesion • Acute coronary syndrome • Cardiogenic shock • Severe kidney disease defined as an eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to investigate percentage diameter stenosis at 1-year follow-up as assessed by intravascular ultrasound (IVUS) in patients successfully treated with PCI CTO randomized to stenting of the CTO body in conjunction with DCB of residual disease compared to stenting of residual disease adjacent to the CTO body. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary invasive imaging objectives are minimal lumen diameter, late luminal loss, in-segment binary restenosis, and target vessel re-occlusion at 1-year follow-up. Secondary clinical objectives are evaluation of the occurrence of major adverse cardiac events (MACE) at 1-year follow-up. | — |
Countries
Netherlands
Outcome results
None listed