Ischemic cardiomyopathy
Conditions
Interventions
Single-arm registry, with 533 patients over 18 years, with coronary artery lesions treated with coronary stent. Patients will be evaluated observationally. Post-discharge follow-up will occur through
Z95
Sponsors
Microport Scientific Vascular Brasil LTDA
Microport Scientific Vascular Brasil LTDA
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers over 18 years of age; percutaneous coronary intervention in less than 96 hours, performed according local interventional cardiology laboratory routine, with implantation or attempted implantation of one or more Firehawk stents for the treatment of symptomatic ischemic heart disease and/or with objective evidence of myocardial ischemia; patient will be informed of the nature of the study, agree to the follow up and provide written informed consent, approved by the local Ethics Committee.
Exclusion criteria
Exclusion criteria: Planned cardiac or non-cardiac surgery within 6 months of the index procedure; Patient with a life expectancy of less than 12 months; Any significant medical condition that in the investigator's opinion may interfere with optimal patient participation in this study; Participation in another survey in the last 12 months, unless that there may be direct benefit to the research subject; Percutaneous coronary intervention performed for the treatment of non-atherosclerotic coronary heart disease; Percutaneous coronary intervention performed for the treatment of previously implanted stent thrombosis; There are no restrictions regarding the number of lesions or stents treated, the treated arteries or the morphology of the lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined outcome consisting of death from any cause, myocardial infarction, ischemia driven target vessel revascularization during 12 months study follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes at 30 days, 6 month and 12 month follow up, i.e: target lesion revascularization; target vessel revascularization; major adverse cardiac events; cardiac death; non-cardiac death; cardiac death or myocardial infarction; death or myocardial infarction; and stent thrombosis | — |
Countries
Brazil
Contacts
Public ContactMirangela Machado
Outcome results
None listed