coronary artery desease stenosis
Conditions
Interventions
None listed
Sponsors
CID S.p.A.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patient is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for surgical revascularization (CABG) - Target de-novo lesion - Target lesion located in a target vessel with a diameter ranging from 2.5 to 3.75 mm - Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site - patients presenting with at least two vessels disease requiring a staged procedure within 3 months, according to the operator judgement
Exclusion criteria
Exclusion criteria: - patient presenting with acute myocardial infarction with ST elevation - Known allergies to antiplatelets, anticoagulants, contrast medica, sirolimus or cobalt chromium - thrombocytopenia (platet count less than 100,000/mm3) - Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year - participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of 0 µm.] | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of malapposed stent struts at immediate post intervention and at pre-specified OCT follow-ups. [Malapposition is defined as distance >= 80µm from the inner edge of the strut to the vessel wall]; - Percentage of malapposed and uncovered stent struts at pre-specified OCT follow-ups; | — |
Countries
Netherlands
Outcome results
None listed