Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.

All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Inclusion Criteria:

• Age ≥18 and ≤ 80years;
• Symptomatic CAD or documented myocardial ischemic disease;
• Up to 2 de novo lesions on native coronary arteries;
• Lesion length ≤ 29mm;
• Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
• Stenose at target lesion ≥ 70% and ≤ 99%.

Exclusion Criteria:

• STEMI within the last 72 hours pre-procedure;
• renal insufficiency;
• Left Main stenosis > 50%;
• Ostial lesions;
• Bifurcation lesions with side branch ≥2mm;
• More than one lesion > 50% at the target vessel;
• Left Ejection Fraction less than 30%;
• Previous (less than 6 months) PCI at the target vessel.