SMT’s Supraflex Cruz DES Evaluated in European CRUZ SENIOR Trial of Octo- and Nonagenarian Patients

July 27, 2021—The Institute for Myocardial Infarction Research (IHF GmbH) in Ludwigshafen, Germany, announced the commencement of enrollment in the CRUZ SENIOR study. The first patient was enrolled on June 23 in Germany.

CRUZ SENIOR is a prospective, multicenter, single-arm, noninterventional, observational clinical investigation that is designed to enroll 2,500 octo- and nonagenarian all-comer patients with coronary artery disease (CAD) at 47 centers in Germany, Austria, Switzerland, and France. The postmarket registry will evaluate patients who underwent percutaneous coronary intervention (PCI) using at least one Supraflex Cruz sirolimus-eluting stent (Sahajanand Medical Technologies Pvt Ltd. [SMT]), as per current practice. Patients will be followed-up for 12 months.

According to IHF, CRUZ SENIOR involves all-comer patients (age, ≥ 80 years) affected by acute coronary syndrome, stable angina, or silent angina. These patients qualify for PCI according to European Society of Cardiology treatment guidelines and physicians’ clinical routine estimation. The objective of this study is to evaluate the results of Supraflex Cruz in an aged real-life patient cohort representing a significant, complex, high-risk patient cohort for PCI in daily routine.

CRUZ SENIOR will also prospectively assess the clinical and patient-reported outcome of PCI for different stages of CAD in representative octo-and nonagenarian all-comer patients. The study will prospectively evaluate new markers representing patients’ functional and frailty status to evaluate new concepts for risk stratification in PCI of aged CAD patients.

The primary endpoint is the device-oriented composite endpoint (per Academic Research Consortium-2) at 12 months, defined as a composite of cardiovascular death, myocardial infarction not clearly attributable to a nontarget vessel, and clinically driven target lesion revascularization.

The study’s coordinating investigator is Professor David M. Leistner, MD, from the Department of Cardiology of Campus Benjamin Franklin, Charité University Hospital in Berlin, Germany.

Prof. Leistner commented in the IHF announcement, “CRUZ SENIOR is a very appropriate study [that] will evaluate the use of ultrathin Supraflex Cruz technology in very old (≥ 80 years) and extremely high-risk patients. So far, Supraflex Cruz in our practice 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.”

The SIBI optical coherence tomography study, which supported CE Mark approval of the device, demonstrated that Supraflex Cruz had approximately 91% endothelialization in 35 days. Atul Abhyankar, MD, et al published the findings in November 2020 in Catheterization and Cardiovascular Interventions.

TALENT is a prospective, multicenter, randomized controlled clinical trial composed entirely of European-based patients with ischemic CAD. The TALENT all-comers results were published in February 2019 by Professor Azfar Zaman, MD, et al in The Lancet (2019;393:987-997).

SMT, which is based in Mumbai, India, announced European CE Mark approval for the Supraflex Cruz in July 2019. SMT has an educational grant for the CRUZ SENIOR study, advised the IHF announcement.