Obseravtional study evaluating the perfomance of the bioabsorbable stent (scaffold) in every day clinical practice
Recruiting
- Conditions
- Patients presenting with NSTEMI stable or unstable angina, or silent
- Registration Number
- NL-OMON27706
- Lead Sponsor
- Investigator Initiated study (Erasmus MC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Patient presenting with NSTEMI stable or unstable angina , or silent ischemia caused by a de novo stenotic lesion in a native previous untreated coronary artery.
2. Dmax (proximal and distal mean lumen diameter) within the upper limit of 3.8 mm and the lower limit of 2.0 mm by online QCA (at the moment only for the 2.5 mm and 3.5 mm devices)
Exclusion Criteria
1. Previous CABG
2. Cardiogenic shock
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Major Adverse Cardiac Events (MACE): defined as cardiac death, re-MI, emergent bypass surgery (CABG), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods at 12 months post-procedure
- Secondary Outcome Measures
Name Time Method