Coronary Stenosis Treated With Implant of Bioresorbable Devices Clinical Trial
Official title:
REgistry of PAtients Treated With bioabsoRbable Devices in dAily Clinical Practice: Costs, Effectiveness, QALYs, and Efficiency. REPARA-QALY Registry
A multicenter, prospective, observational cohort study with clinical, quality of life, and economic evaluation to ascertain the quality-adjusted life years (QALYs) gained by patients with ischemic heart disease revascularized with Absorb in standard clinical practice in Spain. A before-after comparative analysis will be performed, so that each patient will act as his/her own control.
Economical evaluation study of the efficiency of Absorb in a cohort of patients with
ischemic heart disease who have undergone revascularization with Absorb based on the
criteria established according to standard clinical practice. A comparison group without
Absorb cannot be used for ethical reasons. Thus, each patient will act as his/her own
control, and a before-after comparison will be done. This is therefore a prospective,
observational cohort study with concurrent data collection.
Primary objective:
- To assess utility (QALYs gained) in patients implanted Absorb in standard clinical
practice conditions.
Secondary objectives:
- To assess effectiveness (clinical outcomes) in patients who undergo coronary
revascularization with Absorb implantation.
- To assess costs (direct and indirect) derived from coronary revascularization with
Absorb implantation.
- To assess efficiency in terms of cost/utility (cost per QALY gained) and
cost/effectiveness (cost per MACE -major cardiac adverse events- free patient).
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Observational Model: Cohort, Time Perspective: Prospective