Cardiovascular Diseases
Conditions
Brief summary
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.
Detailed description
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 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.
Interventions
DEVICESELUTION SLRTM sirolimus coated balloon
Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Express refusal of the patient to participate in the study * Life expectancy of the patient of less than 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE (Major Adverse Cardiovascular Events) | 12 months | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) |
| TLR | 12 months | Number of Target Lesion Revascularizations |
| DoCE (Device-oriented Composite Endpoint) | 12 months | Incidence of DoCE, defined as Cardiovascular death, device failure-related MI (Myocardial Infarction) or device failure-related ischaemia) |
| PoCE (Patient-oriented Composite Endpoint) | 12 months | Incidence of PoCE defined as all cause death, any stroke, any MI or any revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TLR in ISR | 12 months | Number of Target Lesion Revascularizations in patients with ISR (in-stent restenosis) |
| TLR in primary lesions in native vessel | 12 months | Number of Target Lesion Revascularizations in primary lesions in native vessel |
| TLR in bifurcation side branch lesions | 12 months | Number of Target Lesion Revascularizations in bifurcation side branch lesions |
| MACE (Major Adverse Cardiovascular Events) in ISR | 12 months | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in ISR |
| MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel | 12 months | Incidence of MACE defined as death, non fatal myocardial infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in native vessel |
| MACE (Major Adverse Cardiovascular Events) in bifurcation side branch lesions | 12 months | Incidence of MACE defined as death, nonfatal infarction, or need for TLR (Target Target Lesion Revascularization) in primary lesions in bifurcation side branch lesions |
| Procedure success | 1 day | Device success defined as residual stenosis \<30% by visual assessment and or online QCA (Quantitative Coronary Analysis) \< 40%, absence of dissection and TIMI 3 flow |
| Death | 12 months | Incidence of Death defined as all-cause, cardiac, device related, procedure related |
| Non fatal Myocardial Infarction | 12 months | Incidence of Non fatal Myocardial Infarction |
Countries
Portugal, Spain
Contacts
CONTACTORIOL RODRIGUEZ LEOR, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed