A study to enroll patients between the ages of 80 and 90
The Institute for Myocardial Infarction (IHF GmbH) published the Cruz Advanced Study by enrolling the first patient in Germany on June 23, 2021. Professor David M. Leistner of Charite University Hospital in Berlin is the coordinator of the study. .. Patients from four European countries will participate in this study.
The Cruz Senior Study is a prospective, multicenter, single-arm, non-intervention observational clinical study designed to enroll 2500 October and non-elderly all-visit patients with coronary artery disease. The study enrolled patients from 47 centers in Germany, Austria, Switzerland and France.
According to current practice, patients undergoing percutaneous coronary intervention (PCI) using at least one Supraflex Cruz sirolimus-eluting stent will be followed up for 12 months.
Europe’s population is 25% over the age of 70 and is increasing due to increased life expectancy. Elderly patients are more likely to have other comorbidities such as decreased ejection rate, diabetes, hypertension, severe kidney disease, arrhythmias, and aortic stenosis, and are anatomically presented to the catheterization laboratory. You are more susceptible to complex coronary artery problems that challenge you. Treatment of these anatomical structures requires superior experience, superior technique, complete evidence planning, and stents that have proven efficacy, safety, and delivery capability in the most winding lesions.
Cruz Senior becomes Europe’s largest ongoing enrollment involving all patients (aged 80+) affected by acute coronary syndrome (NSTE-ACS), stable angina, or asymptomatic angina increase. These patients are eligible for PCI according to ESC treatment guidelines and physician clinical routine estimates.
The purpose of this study is to evaluate the results of the Supraflex Cruzsirolimus-eluting coronary stent system in a real-life cohort of elderly people (aged 80+) representing the most complex and high-risk patient cohort of PCI in everyday life. Cruz’s advanced study will positively assess the clinical and patient-reported outcomes (PROMs) of PCI itself for different stages of CAD in all typical eighties and non-elderly patients. This study will positively evaluate new markers of functional and frail patient status and evaluate a new concept of risk stratification in PCI for older CAD patients.
The primary endpoint of the study, the 12-month device-oriented composite endpoint (DOCE by ARC2), is cardiovascular death, myocardial infarction (MI) not clearly due to non-target vessels, and clinically driven targets. It is defined as a complex of lesion revascularization (TLR).
Dr. David M. Reistner, Coordinating Researcher at the Benjamin Franklin Department of Cardiology on the campus of Charite, Berlin, explained the study in more detail. Patients who are very old (80 years or older) and at very high risk. So far, Supraflex Cruz in our practice has been very successful in treating complex patient subsets with very promising results. With best-in-class deliverability, unobtrusive, rapid healing experience from previous SIBI studies, and long-term results from talent trials, Supraflex Cruz is a plus for this highly risky patient population. I sincerely hope that it will have an impact. “
SMT provides educational grants to the Cruz Senior Study.
Cruz Senior trial starts with Supraflex Cruz in Europe Source link Cruz Senior trial starts with Supraflex Cruz in Europe