Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety.
The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.
Patients with age ≥18 years and;
Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;
Patient who has been informed of the characteristics of the study and has provided written informed consent.
Express refusal of the patient to participate in the study
Life expectancy of the patient of less than 12 months
All patients treated with the Selution SLRTM device
Case-only
Prospective
SELUTION SLRTM sirolimus coated balloon
DevicePatients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted
MACE (Major Adverse Cardiovascular Events)
Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization)
TLR
Number of Target Lesion Revascularizations
DoCE (Device-oriented Composite Endpoint)
Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia)
PoCE (Patient-oriented Composite Endpoint)
Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization
TLR in ISR
Number of Target Lesion Revascularizations in patients with ISR (in-stent restenosis)
TLR in primary lesions in native vessel
Number of Target Lesion Revascularizations in primary lesions in native vessel
TLR in bifurcation side branch lesions
Number of Target Lesion Revascularizations in bifurcation side branch lesions
MACE (Major Adverse Cardiovascular Events) in ISR
Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in ISR
Click on the lead sponsor to view all of their trials.
