Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

SELUTION SLRTM sirolimus coated balloon: Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (16)

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