November 3, 2020
Enrollment Completed for SMT’s Cruz HBR Registry Evaluating Supraflex Cruz in High Bleeding Risk Patients
November 3, 2020—Sahajanand Medical Technologies Pvt. Ltd. (SMT) announced that it has completed the patient enrollment for the Cruz HBR Registry. The results are expected by the end of 2021.
From February 19 to October 16, 2020, the registry enrolled 1,200 patients at 26 centers in France, Germany, and Switzerland. Of these patients, 400 were at high bleeding risk, and 800 were not high bleeding risk. The study’s principal investigator is interventional cardiologist Professor Christoph Naber, MD, from Klinikum Wilhelmshaven in Wilhelmshaven, Germany.
According to the company, this registry is a prospective, multicenter, single-arm registry evaluating the safety and efficacy of SMT’s Supraflex Cruz sirolimus-eluting coronary stent system in the percutaneous coronary intervention treatment of all-comer patients with coronary artery disease.
The real-life registry is intended to confirm the results from the TALENT clinical trial. The secondary objective of this registry is to demonstrate that the Supraflex Cruz stent is noninferior to the polymer-free BioFreedom drug-coated stent (Biosensors International Group Ltd) among high bleeding risk patients.
The benefits of ultrathin Supraflex Cruz stent will be evaluated for the first time in the high-bleeding risk patient population, a very complex population at a high risk of bleeding and ischemia.
Addressing the evaluation process, Prof. Naber commented, “I am sure the results of this registry will prove very useful for the colleagues out there in the cath labs. While TALENT trial showed excellent data for the Supraflex family of stents, Cruz HBR will extend our knowledge to all-comers and patients with high bleeding risk.”
The contract research organization for this study is Cardiovascular European Research Centre (CERC), based in Massy, France. Marie-Claude Morice, MD, CEO of CERC, stated, “CERC team is very grateful to the Cruz HBR investigators, who recruited faster than expected all 1,200 patients despite the COVID-19 period. The entire CERC team was mobilized to follow this rapid pace effectively.”
SMT is a global medical device company based in Mumbai, India. The company announced European CE Mark approval for the Supraflex Cruz in 2019. In June 2020, SMT announced it has received the full reimbursement confirmation for its Supraflex and Supraflex Cruz coronary heart stents from the Ministry of Health and Public Affairs of France.