Chronic Total Coronary Occlusion (CTO) Chronically Occluded Coronary
Conditions
Interventions
The Drug-Coated Balloon (Agent, Boston Scientific Inc.).
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age = 18 yearsClinical 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 lesion
Exclusion criteria
Exclusion criteria: Unfavorable characteristics for DCB-angioplasty, including: dissection affecting the flow ([TIMI] score<3), significant recoil (>30%) or coronary perforation following predilationReference diameter of the vessel is <2.5 mm or >4.0 mmBifurcation lesion requiring the stenting of the side branchPrior extensive stent-placement (presence of a continuous segment of intracoronary stenting >60 mm or ‘full metal jacket’)Left main lesionAcute coronary syndromeCardiogenic shockSevere kidney disease defined as an eGFR < 30 ml/minPregnancyLife expectancy < 12 monthsInability to give written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is late luminal loss at 1 year follow up, as assessed by intravascular ultrasound (IVUS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary invasive imaging parameters include percentage diameter stenosis, minimal lumen diameter, 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
Contacts
Public ContactYBO Somsen
Amsterdam UMC
Outcome results
None listed