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Cruz Senior Trial Starts with Supraflex Cruz in Europe

Business Wire India
Release summary

Study to enrol patients between the age of 80 and 90 years
Study aims to evaluate ultra-thin biodegradable polymer Supraflex Cruz Sirolimus-eluting Coronary Stent System in the treatment of Octo- and Nonagenarian (patients above the age of 80 yrs) all-Comer patient

Institute for Myocardial Infarction Research (IHF GmbH) has announced Cruz Senior Study by enrolling its first patient in Germany on 23rd June. Prof. Dr. David M. Leistner from the Charité University Hospital, Berlin, is the Coordinating Investigator of the study. Patients from 4 countries across Europe will be participating in this study.

Cruz Senior study is a prospective, multi-centre, single-armed, non-interventional observational clinical investigation which is designed to enrol 2500 octo-and nonagenarian all-comer patients with coronary artery disease. The study will take patients from 47 centres from Germany, Austria, Switzerland, and France.

Patients who underwent percutaneous coronary intervention (PCI) using at least one Supraflex Cruz sirolimus-eluting stent as per current practice and will be followed up for 12 months.

Europe has 25% population above 70 years old and its rising due to increasing life expectancy. Elderly patients have high chances of other co-morbidities like low ejection fraction, diabetes, high blood pressure, severe kidney disease, arrhythmia, aortic stenosis, etc making them susceptible to complex coronary issues challenging anatomies, when presented in the cath lab. Treating these anatomies needs remarkable experience, outstanding technique, full proof planning and a stent with proven efficacy, safety, and ability to deliver in the most tortuous lesions.

Cruz Senior will be the biggest ongoing registry in Europe which involves all-comer patients (≥80 years) affected by acute coronary syndrome (NSTE-ACS), stabile angina or silent angina. These patients qualify for PCI according to ESC-treatment guidelines and physicians’ clinical routine estimation.

The objective of this study is to evaluate the results of the Supraflex Cruz sirolimus-eluting coronary stent system in an aged (≥80 years) real-life patient cohort representing a significant most complex high-risk patient cohort for PCI in daily routine. Cruz Senior Study will also assess prospectively, the clinical and patient-reported outcome (PROM) of PCI itself for different stages of CAD in a representative octo-and nonagenarian all-comer patients. The study will prospectively evaluate new markers representing functional and frailty patients ́status to evaluate new concepts for risk stratification in PCI of aged CAD-patients.

Primary endpoint of the study, Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR).

Elaborating more about the study, Coordinating Investigator Prof. Dr. David M. Leistner from the Department of Cardiology of Campus Benjamin Franklin, Charité in Berlin, said, “Cruz Senior is a very appropriate study which will evaluate the use of ultrathin Supraflex Cruz technology in very old (80+) and extremely high-risk patients. So far, Supraflex Cruz in our practise has been very successful in treating complex patient subsets with extremely promising results. We sincerely wish Supraflex Cruz with the best-in-class deliverability, low profile, quick healing experience from the previous SIBI study and long-term results obtained from Talent trial will have positive impact on this exceedingly high-risk patient population.”

SMT has given an educational grant for the Cruz Senior Study.

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