SMT Completes Enrolment of Cruz HBR Registry to Further Evaluate the Safety and Efficacy of Supraflex Cruz in High Bleeding Risk Patients

Business Wire India

Release summary points

• 1200 {800 non-High Bleeding Risk (non-HBR) and 400 High Bleeding Risk (HBR) patients are involved in the registry}


• 26 sites in 3 countries (France, Germany, Switzerland)

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SMT (Sahajanand Medical Technologies Pvt. Ltd.), global manufacturer of cardiovascular medical devices, today announced that it has completed the patient enrolment for Cruz HBR Registry. Patient enrolment had started on February 19, 2020 and ended on October 16, 2020. The registry was conducted in France, Germany and Switzerland comprising of 26 sites.
 
This registry is a prospective, multi-center, single-arm registry to evaluate the safety and efficacy of Supraflex Cruz sirolimus-eluting coronary stent system in the treatment of all-comer patients with coronary artery disease by Percutaneous Coronary Intervention, to confirm the results from the TALENT trial in real life.
 
The secondary objective of this registry is to demonstrate that Supraflex Cruz stent is not inferior to BioFreedom™ stent amongst High Bleeding Risk patients. High bleeding risk patients are very complex set of population who are at a high risk of bleeding and high ischemic risk. The benefits of ultrathin Supraflex Cruz stent in this patient population will be evaluated for the first time in this study. The CRO for this study is Cardiovascular European Research Centre (CERC), France which carries a high reputation of conducting many landmark studies very successfully.
 
The study evaluates a total of 1200 patients amongst which 800 patients are having non-High Bleeding Risk and 400 patients possess bleeding risk factor. The study has been commenced under Principal Investigator and Senior Interventional Cardiologist Prof. Christoph Naber (Klinikum Wilhelmshaven), Germany.
 
Speaking more about the evaluation process, Principle Investigator Prof. Christoph Naber said, "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 Stent, Cruz HBR will extend our knowledge to all-comers and patients with high bleeding risk.”
 
Adding on the study front, the CEO of CERC, Dr Marie-Claude Morice said, "CERC team is very grateful to the Cruz HBR investigators, who recruited faster than expected all 1200 patients despite the Covid-19 period. Entire CERC team was mobilized to follow this rapid pace effectively."
 
Study pointers
Total No. of Patients: 1200 (800 non-High Bleeding Risk (non-HBR) and 400 HBR)
Principal Investigator: Prof. Christoph Naber, Klinikum Wilhelmshaven, Germany
CRO: Cardiovascular European Research Center (CERC), France
Locations: 26 sites in 3 countries (France, Germany, Switzerland)
Study Start Date: February 19, 2020
 
The results of HBR Cruz Registry are expected by the end of year 2021.
 
BioFreedom™ is a polymer- and carrier-free Drug Coated Stent with BA9™ (DCS) by Biosensors International.
*Supraflex Cruz is a trademark of Sahajanand Medical Technologies Pvt. Ltd. or its affiliates.