Mrs. Blueberry’s SMB to evaluate the safety of the nomination of the HRB registry and the safety and efficacy of the Superflex cruise in patients with high bleeding risk – Tech

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Business Wire India
Issue summary score

  • 1200 {800 non-high bleeding risk (non-HBR) and 400 high bleeding risk (HBR) patients are included in the registry}
  • 26 sites in 3 countries (France, Germany, Switzerland)

SMT (Sahajanand Medical Technologies Private Limited), a global manufacturer of cardiac medical devices, today announced that it has completed enrollment for the patient. Cruise hbr registry. Patient enrollment was started Ended on February 19, 2020 and October 16, 2020. The registry was organized in France, Germany and Switzerland which included 26 sites.

This registry is a prospective, multi-center, single-handed registry for evaluation of safety and efficacy. Superflex cruise Sirolimus-eluting coronary stent system in the treatment of all-comrade patients with coronary artery disease by percutaneous coronary intervention, to confirm with results Talent Testing in real life.

The secondary purpose of this registry is to demonstrate that Superflex Cruise is not inferior to a Biofreedom ™ stent among patients with high bleeding risk. Patients with high bleeding risk are a very complex group of population who are at high risk of bleeding and high ischemic risk. The benefits of ultrathin supraflex cruise stents in this patient population will be evaluated for the first time in this study. The CRO for this study is the Cardiovascular European Research Center (Circle), France which has a high reputation for successfully conducting many historical studies.

The study evaluated a total of 1200 patients, with 800 patients with non-high bleeding risk and 400 patients with bleeding risk factor. This study was conducted by Germany’s Principal Investigator and Senior Interventional Cardiologist Prof. Is started under Christoph Naber (Clinicum Wilhelmshaven).

Talking more about the evaluation process, Principal Investigator Pro. Christophe Naber said, “I am sure that the results of this registry will prove very useful to outside colleagues in the cath lab. While the Talent test showed excellent data for the Suplex family of stents., Cruise HBR is known to all experts and for high bleeding.” Will expand our knowledge to patients. “

Adding to the study front, CERC CEO Drs. Marie-Claude Morris said, “The CERC Team Cruise is very grateful to the HBR investigators who recruited faster than all 1200 patients despite the Kovid-19 period. The Antire CERC team was mobilized. This rapid pace effectively To follow from. “

Study signs
Total number of patients: 1200 (800 non-high bleeding risk (non-HBR) and 400 HBR)
Chief Investigator: Pro. Christophe Naber, Wilhelmshaven Clinic, Germany
CRO: Cardiovascular European Research Center (CERC), France
place: 26 sites in 3 countries (France, Germany, Switzerland)
Study Start Date: 19 February 2020

The results of the HBR Cruise Registry are expected by the end of the year 2021.

BioFreedom ™ is a polymer and carrier-free drug coated stent with BA9 ™ (DCS) by Biosensors International.
* Supraflex is a trademark of Cruise Sahajanand Medical Technologies Pvt. Ltd. or its affiliates.

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