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The objective is to evaluate the efficacy and safety of the Inspironâ„¢ 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 Inspironâ„¢ EVO drug-eluting stent.
Post-marketing, observational, prospective, multi-center, non-randomized, single-arm registry that will include all patients who receive the Inspironâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Percutaneous coronary intervention (PCI) | Patients with symptomatic ischemic heart disease due to lesions in the native coronary artery and restenotic lesions treated with the Inspironâ„¢ EVO drug-eluting stent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiron EVO Drug-Eluting Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 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). | 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). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspironâ„¢ EVO Drug-Eluting Stent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Aurélio A Costa, MD, PhD | Contact | +1 216 903-9327 | marco.costa@scitechmed.com | |
| Ana Paula B Pellaquim, MSc. | Contact | +55 62 9471-4439 | aalmeida@scitechmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Paulo Ricardo A Caramori, MD | PontifÃcia Universidade Católica do Rio Grande do Sul (PUCRS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PontifÃcia Universidade Católica do Rio Grande do Sul (PUCRS) | Porto Alegre | Rio Grande do Sul | 90610000 | Brazil |
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|
| Target vessel revascularization rate (TVR) |
TVR is defined as revascularization of any segment of the target coronary artery. |
| 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. | 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. | 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. | 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. | 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. | 6 months |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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