The CRUZ SENIOR research, which is being conducted by the Institute for Myocardial Infarction Research (IHF GmbH) in Ludwigshafen, Germany, has begun enrolling participants in its first phase. The first patient was registered on June 23 in Germany, according to the company. The CRUZ SENIOR study is a non-interventional, prospective, observational, single-arm, multi-center clinical investigation that includes 2,500 octo- and nonagenarian all-comer patients diagnosed with coronary artery disease (CAD) at their various centers in Europe. In addition, patients who received the percutaneous coronary intervention (PCI) with a minimum of one Supraflex Cruz sirolimus-eluting stent of Sahajanand Medical Technologies Pvt Ltd. (SMT) will be evaluated during the post-market registry. The Follow-up will be done at 12 months.
All-comer patients aged more than 80 years suffering from silent angina, stable angina, or acute coronary syndrome will be included in the CRUZ SENIOR study, as per IHF. Moreover, as per the treatment guidelines by the European Society of Cardiology and estimation by physicians’ clinical routine, such patients can undergo PCI, and the results of Supraflex Cruz will be evaluated in a real-life patient cohort.
On the other hand, the CRUZ SENIOR trial will prospectively evaluate the patient-reported and clinical PCI outcomes for various CAD stages regarding octo- and nonagenarian all-comers. In addition, novel markers indicating patients' frailty and functional status will be evaluated prospectively in this study to assess elderly CAD patient-related new theories for risk classification in percutaneous coronary intervention.
At 12 months, the device-oriented composite endpoint will be measured for the primary endpoint, also defined as a combination of clinically driven revascularization of the target lesion, myocardial infarction not connected explicitly to a non-target vessel, and cardiovascular death. As per Prof. Leistner, ultrathin Supraflex Cruz has been successful and effective in his practice in treating high-risk patients and has wished Supraflex Cruz extraordinary and positive outcomes based on the SIBI study obtained from the TALENT trial.
Lastly, SMT received the CE Mark approval in July 2019 for Supraflex Cruz, and an educational grant was provided for the CRUZ SENIOR study by IHF.