Neointimal hyperplasia Stenosis
Conditions
Interventions
None listed
Sponsors
Sorin Biomedica Cardio - Vascular Therapy BU
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects >18 years of age Subjects who are eligible for CABG surgery Subjects diagnosed with the-novo coronary lesion(s) with a diameter stenosis >50% and
Exclusion criteria
Exclusion criteria: Subjects involved in other clinical trials with any investigational drug or device Women who are pregnant or who have the potential to become pregnant during the study Subjects previously implanted with a coronary stent in the target lesion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adjudicated composite rate of cardiac death, MI, clinically driven TLR at 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adjudicated composite rate of all death, MI, TVR at 6 months, 1 and 2 years Adjudicated thrombosis rate according to ARC (Academic Research Consortium) definition for each follow-up period; LLL (Late Lumen Loss) at 8 months (subgroup analysis) | — |
Countries
Netherlands
Outcome results
None listed