The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population. Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions will be treated with the Inspiron™ EVO drug-eluting stent.
Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI).
Individuals who provide consent and are willing to comply with the follow-up protocol.
Individuals who received treatment with the Inspiron™ EVO Stent.
Individuals with lesions ≥ 30 mm in length (Subprotocol 1).
Lesions in saphenous vein grafts or internal mammary grafts.
Contraindication to the use of a drug-eluting stent.
Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.
Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.
Cohort
Prospective
Inspiron EVO Drug-Eluting Stent
DevicePercutaneous coronary intervention (PCI) using the Inspiron EVO Drug-Eluting Stent, which has a reduced crimped profile, providing greater safety and facilitating lesion crossing. In addition, the design is optimized to provide increased radial strength.
Device success
Device success (at the lesion level) is defined as the successful delivery, balloon expansion, and implantation of the first device at the target lesion (with multiple attempts using the same device permitted), successful withdrawal of the delivery system, and achievement of a final in-stent residual stenosis of \<20%
Acute Clinical Success of Percutaneous Coronary Intervention (PCI)
Defined as the absence of major adverse in-hospital cardiac events (death, myocardial infarction, or repeat coronary revascularization of the target lesion).
MACE (Major Adverse Cardiac Events) rate
Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR).
Target Lesion Revascularization (TLR) rate
TLR is defined as any percutaneous reintervention of the target lesion, including the 5 mm proximal and 5 mm distal segments of the stent, or revascularization of the target vessel, performed for clinical reasons due to restenosis or occlusion of the target lesion.
Target vessel revascularization rate (TVR)
TVR is defined as revascularization of any segment of the target coronary artery.
Target Vessel Failure Rate (TVF)
Defined as a combination of MI, TLR, or cardiovascular death related to the target vessel. If it is not possible to determine with certainty whether the MI or death was related to the target vessel, the case is considered a TVF.
Rate of definite, probable, and possible stent thrombosis (ST)
Stent thrombosis is classified as definite, probable, or possible: definite requires angiographic or pathological confirmation; probable includes unexplained death within 30 days or myocardial infarction related to the stented territory without angiographic confirmation; and possible refers to any unexplained death occurring from 30 days after implantation until the end of follow-up.
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