Vascular Response to Everolimus-eluting Bioresorbable Vascular Scaffold Implantation in patients with Diabetes Mellitus
- Conditions
- angina pectoriscoronary sclerosis10011082
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
1. Patient is at least 18 years of age.
2. Patient is know with diabetes mellitus
3. 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
4. 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)
5. The patient understands and accepts the meaning and the aims of the study
6. The patient is willing to comply with specified follow-up evaluation and can be contacted by telephone (Signed Informed Consent)
1. Previous CABG
2. Cardiogenic shock
3. STEMI patients requiring immediate stent implantation
4. Bifurcation lesion requiring kissing balloon postdilatation
5. Allergies or contraindications to antiplatelet medication or contrast material
6. Female patient with child bearing potential not taking adequate contraceptives or currently breasfeeding
7. Expected survival of < 1 year
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the evaluation of the scaffold coverage at 6-month<br /><br>follow-up by invasive coronary imaging with Optical Coherence Tomography.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary objectives of the present investigation include OCT, QCA, NIRS<br /><br>imaging (baseline and 6 month) and clinical endpoints (until 5 years follow-up)</p><br>