eOPTIMA Registry
Phase 4
Withdrawn
- Conditions
- Neointimal hyperplasiaStenosis10011082
- Registration Number
- NL-OMON32685
- Lead Sponsor
- Sorin Biomedica Cardio - Vascular Therapy B
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 100
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 <100% (visual estimation)
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of adjudicated composite rate of cardiac death, MI, clinically driven<br /><br>TLR at 6 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>Incidence of adjudicated composite rate of all death, MI, TVR at 6 months, 1<br /><br>and 2 years<br /><br>Adjudicated thrombosis rate according to ARC (Academic Research Consortium)<br /><br>definition for each follow-up period; LLL (Late Lumen Loss) at 8 months<br /><br>(subgroup analysis)</p><br>