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04 Jun 2023, 00:08 HRS IST
  • PTI
  • Cruz Senior Trial Starts with Supraflex Cruz in Europe

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13:45 HRS IST

(Eds: Disclaimer: The following press release comes to you under an arrangement with Business Wire India. PTI takes no editorial responsibility for the same.)

Mumbai, Maharashtra, India Business Wire India Release summary Study to enrol patients between the age of 80 and 90 years Study aims to evaluate ultra-thin biodegradable polymer Supraflex Cruz Sirolimus-eluting Coronary Stent System in the treatment of Octo- and Nonagenarian (patients above the age of 80 yrs) all-Comer patient Institute for Myocardial Infarction Research (IHF GmbH) has announced Cruz Senior Study by enrolling its first patient in Germany on 23rd June. Prof. Dr. David M. Leistner from the Charit University Hospital, Berlin, is the Coordinating Investigator of the study. Patients from 4 countries across Europe will be participating in this study.

Cruz Senior study is a prospective, multi-centre, single-armed, non-interventional observational clinical investigation which is designed to enrol 2500 octo-and nonagenarian all-comer patients with coronary artery disease. The study will take patients from 47 centres from Germany, Austria, Switzerland, and France.

Patients who underwent percutaneous coronary intervention (PCI) using at least one Supraflex Cruz sirolimus-eluting stent as per current practice and will be followed up for 12 months.

Europe has 25% population above 70 years old and its rising due to increasing life expectancy. Elderly patients have high chances of other co-morbidities like low ejection fraction, diabetes, high blood pressure, severe kidney disease, arrhythmia, aortic stenosis, etc making them susceptible to complex coronary issues challenging anatomies, when presented in the cath lab. Treating these anatomies needs remarkable experience, outstanding technique, full proof planning and a stent with proven efficacy, safety, and ability to deliver in the most tortuous lesions.

Cruz Senior will be the biggest ongoing registry in Europe which involves all-comer patients (=80 years) affected by acute coronary syndrome (NSTE-ACS), stabile angina or silent angina. These patients qualify for PCI according to ESC-treatment guidelines and physicians' clinical routine estimation.

The objective of this study is to evaluate the results of the Supraflex Cruz sirolimus-eluting coronary stent system in an aged (=80 years) real-life patient cohort representing a significant most complex high-risk patient cohort for PCI in daily routine. Cruz Senior Study will also assess prospectively, the clinical and patient-reported outcome (PROM) of PCI itself for different stages of CAD in a representative octo-and nonagenarian all-comer patients. The study will prospectively evaluate new markers representing functional and frailty patients status to evaluate new concepts for risk stratification in PCI of aged CAD-patients.

Primary endpoint of the study, Device Oriented Composite Endpoint (DOCE as per ARC2) at 12 months defined as composite of cardiovascular death, myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (TLR).

Elaborating more about the study, Coordinating Investigator Prof. Dr. David M. Leistner from the Department of Cardiology of Campus Benjamin Franklin, Charit in Berlin, said, "Cruz Senior is a very appropriate study which will evaluate the use of ultrathin Supraflex Cruz technology in very old (80+) and extremely high-risk patients. So far, Supraflex Cruz in our practise 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. SMT has given an educational grant for the Cruz Senior Study.

About Supraflex Cruz

Cruz design provides physicians an access to difficult and tortuous lesions which were very challenging in their practice. The stent retains all the benefits of the Supraflex stent or the previous Supra Family of stents, viz, Ultrathin strut thickness (60 microns for all diameters and lengths), blend of proprietary biodegradable polymers to release the drug, very thin layer of polymers, high radial strength, low crossing profile. The Supraflex Cruz has a very large and extensive size matrix. 1 set consist of 88 skus and covers diameters from 2.0 to 4.5 and lengths from 8 mm to 48 mm. This size matrix ensures that the physician and the patient does not need to make any compromise of accommodating a shorter or a longer stent inside the coronaries.

About SMT SMT (Sahajanand Medical Technologies Limited) is a global developer and manufacturer of minimally invasive cardiovascular devices including coronary, structural heart and occluders devices. SMT continues to upgrade its product portfolio to cater to the healthcare needs. SMT has a global presence, and it has received recognitions from the Ministry of Health Sciences & Technologies for its contributions in the field of Coronary healthcare. SMT is committed to advance the patient care by introducing quality medical devices to serve patients. SMT has acquired Vascular Concepts Limited in the year 2020.

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