Six-Month Clinical and Angiographic Follow up of Everolimus eluting bioresorbable vascular scaffold in patients presenting with ST-segment elevation myocardial infarctio
Completed
- Conditions
- stent couveragestrut apposition10011082
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Patient is at least 18 years of age.
2. Patient has been treated, within the previous 6 month, with BVS for primary PCI .
3. For the pre-specified subgroup of 30 patients, an OCT study of the treated culprit lesion after BVS implantation should be available for analysis.
4. Treated target lesion must be a de-novo lesion located in a native vessel.
5. Signed Informed Consent.
6. The patient understands and accepts the meaning and the aims of the study
Exclusion Criteria
1. Pregnancy.
2. Known intolerance to contrast material.
3. Known thrombocytopenia (PLT< 100,000/mm3).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the evaluation of the healing process defined as<br /><br>scaffold apposition and coverage at 6-month follow-up by invasive coronary<br /><br>imaging with Optical Coherence Tomography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary OCT objective is the serial assessment of strut apposition from<br /><br>baseline to 6-month follow-up in a subgroup of patients where an OCT study has<br /><br>been performed at baseline, as clinically indicated.</p><br>