Calcific Coronary Arteriosclerosis, Complex Coronary Lesions, Coronary Artery Disease (CAD), Multivessel Coronary Artery Disease, Small Vessel Ischemic Disease, Stenosis Coronary
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInspiron 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.
Sponsors
Scitech Produtos Medicos SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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). * Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC/AHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2). * Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3). * Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4).
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device success | Initial procedure | 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) | Up to 24 hours | 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 | 12 months | Defined as the combination of cardiac death, myocardial infarction (MI), or revascularization of the target lesion (TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Revascularization (TLR) rate | 12 months | 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) | 12 months | TVR is defined as revascularization of any segment of the target coronary artery. |
| Target Vessel Failure Rate (TVF) | 12 months | 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) | 12 months | 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. |
| Cardiovascular mortality | 12 months | 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. |
| Late in-segment luminal loss (including the in-stent portion and the 5-mm proximal and distal edges) | 6 months | 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. |
| Percent Area Stenosis (%AS) | 6 months | Defined as the ratio between the neointimal hyperplasia area and the stent area multiplied by 100 at the 6-month follow-up. |
Countries
Brazil
Contacts
CONTACTMarco Aurélio A Costa, MD, PhD
CONTACTAna Paula B Pellaquim, MSc.
PRINCIPAL_INVESTIGATORPaulo Ricardo A Caramori, MD
Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)
Outcome results
None listed