REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice (REPARA)

The patients will be included consecutively at each site for one year. They will be individuals from both sexes, requiring endovascular intervention and meeting the authorised criteria for the indications of use of the device to be used and where dual anti-platelet therapy (DAPT) with aspirin and thienopyridines is considered.

STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary device in patients with de novo coronary artery lesions, where a follow-up of 12 months will be performed.

Primary objective:

MACE rate at 12 months of follow-up:

Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).

Secondary objectives:

• Angina
• Death due to any cause.
• Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)
• All TLR driven or not by ischaemia
• All TVR driven or not by ischaemia.
• All coronary revascularisations performed (PCI vs CABG)
• Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable, possible).
• Immediate success of the device.
• Immediate success of the procedure.
• Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and relationship with the occurrence of events
• Composite endpoints:

Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))

• Rate of overlapping devices: characteristics and relationship with occurrence of events
• Collection of imaging data of the cases where, according to the judgement of the investigator, intravascular imaging tests have been performed (IVUS, OCT).