An observational study in Coronary Artery Disease (CAD), Stenosis Coronary and Small Vessel Ischemic Disease, sponsored by Scitech Produtos Medicos SA. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Scitech Produtos Medicos SA · Observational
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.
Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspiron™ EVO stent at participating sites and meet the eligibility criteria.
Up to 2,000 patients are expected to be enrolled across 12 research sites in Brazil. Participants' demographic, procedural, and follow-up data will be collected for up to 12 months in this study.
Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.
Exclusion Criteria:
Patients with symptomatic ischemic heart disease due to lesions in the native coronary artery and restenotic lesions treated with the Inspiron™ EVO drug-eluting stent.
Device: Inspiron EVO Drug-Eluting Stent
Percutaneous 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%
Time frame: Initial procedure
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).
Time frame: Up to 24 hours
MACE (Major Adverse Cardiac Events) rate
Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR).
Time frame: 12 months
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.
Time frame: 12 months
Target vessel revascularization rate (TVR)
TVR is defined as revascularization of any segment of the target coronary artery.
Time frame: 12 months
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.
Time frame: 12 months
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.
Time frame: 12 months
Cardiovascular mortality
Any death due to an immediate cardiac cause (e.g., myocardial infarction, low-output heart failure, fatal arrhythmia), unwitnessed death, death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment, will be classified as cardiac death.
Time frame: 12 months
Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges)
Defined as the difference between the in-segment minimum luminal diameter (MLD) (including the in-stent portion and the 5-mm proximal and distal edges) after the procedure and the MLD at the 6-month follow-up, as determined by quantitative angiography.
Time frame: 6 months
Percent Area Stenosis (%AS)
Defined as the ratio between the neointimal hyperplasia area and the stent area multiplied by 100 at the 6-month follow-up.
Time frame: 6 months
Plan to share: No
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Scitech Produtos Medicos SA