28.01.2022 – 18:49
Concept Medical Inc.
Milan, Italy (ots / PRNewswire)
FONDAZIONE Ricerca e Innovazione Cardiovascolare, Milan, which specializes in cardiovascular research, announces the first patient recruitment for TRANSFORM II, a randomized controlled studio (sirolimus-coated balloon versus drug-eluting stent in native coronaries), initiating a pivotal study in the field of native coronary treatment.
The randomized controlled studio TRANSFORM II, designed to research and evaluate treatment options in native coronary vessels, was established on December 16, 2021 at the Sandro Pertini Hospital in Rome by the team of Drs. Alessandro Sciahbasi performed.
The international, multicentric, prospective, led by investigators, open-label, randomized study to monitor and evaluate the efficacy of the sirolimus-coated balloons Magic Touch (Concept Medical Inc.) in a direct comparison with the everolimus eluting stent (EES), which is considered the gold standard, in a 1:1 randomization in the native coronary vessels. The study is led by study leader Dr. Bernardo Cortese from the San Carlo Clinic, Paderno Dugnano-Milano, Italy. In addition to him, the steering committee includes Dr. Roxana Mehran, Dr. Alexandre Abizaid, Dr. Stefano Rigattieri, Dr. Fernando Alfonso, Dr. Jose Maria de la Torre Hernandez and Dr. Peter Smith on.
The idea of stenting small or moderately sized de novo coronary lesions is neither desirable nor efficient given the heavy metal scaffolding of the vessel. Interventionalists of the newer generation are rather reluctant to load the vessel with a metal framework in this situation. Drug eluting balloons (DCB) therefore offer a better option in the treatment of native coronary artery lesions.
A total of 1325 patients will be included in the study. The study population consists of patients over 18 years of age with a clinical indication for native vessel PCI (stable CAD or acute coronary syndrome). Native coronary artery lesions in a vessel with a diameter of >2.0 mm and ≤3.0 mm with a maximum lesion length of 40 mm (an achievement for this type of study) are included in further randomization to Magic Touch or EES intervention .
The aim of the study is to evaluate Magic Touch compared to EES with the primary endpoint of non-inferiority for target lesion regurgitation (TLF), a composite of cardiac death, ischemia-related target lesion revascularization (TLR), and myocardial infarction (MI) at 12 months. The study will also verify and measure the superiority of the study device in terms of net adverse clinical events (NACE) using the co-primary endpoint of all-cause death, myocardial infarction, ischemic stroke and major bleeding (BARC – 3 or 5). . Follow-up is at 6 months and annually for 5 years. An OCT substudy will be conducted in a total of 70 patients who will receive a 9-month angio and OCT follow-up with core lab analysis.
were for years drug-eluting stents the preferred option in native vessels. However, thanks to newer and advanced DCB technologies, surgeons now have access to an alternative where they don’t have to worry about metal in these vessels and can achieve good results. The ongoing randomized controlled trial TRANSFORM 1 comparing sirolimus and paclitaxel DCB in small coronary vessels: Magic Touch (Concept Medical Inc.) and SeQuent Please NEO (B. Braun) is progressing rapidly with more than 50% of patients already enrolled, and TRANSFORM II is the perfect randomized controlled trial to find further answers for the treatment of native coronary arteries.
dr Bernardo Cortese is optimistic and excited about the start of the randomized controlled trial. He briefly explains why this is a much needed study and what is expected of it: “We need not expect a stent-like outcome when using a DCB; what we’re aiming for is similar outcomes to DES and potentially better outcomes over the long term because we don’t implant metal and metal in stents is associated with a small but steady year-on-year increase in adverse events,” said Dr. Cortese. Cortese quotes: “With DCB, at least when using a reliable device, we observed a flattening of the event curve at 18 months, so why not expect better results at 3-4 years?”
Essentially, TRANSFORM II will unearth data suggesting why the transition from stents to balloons is a necessity in some native coronaries. Hopefully the data will show encouraging and promising results in the near future.
Magic Touch, ein Sirolimus Coated Balloon , has already received breakthrough device designation from the US FDA for the treatment of small coronary vessels and in-stent restenosis. This attempt can make the use of DCB like the Magic Touch preferred. This can be an indication that it is time to change.
About Magic Touch:
Magic Touch is Concept Medical’s CE-marked and commercially marketed sirolimus-coated balloon, manufactured using the proprietary Nanolute-Technology was developed. Magic Touch has been used on more than 50,000 patients in key global markets. Nanoluté – the Magic Touch balloon’s unique drug delivery technology platform – is designed to deliver submicron sirolimus particles, which are then encapsulated in a biocompatible drug carrier. The carrier complex is designed to reach the deepest layers of the vascular walls.
Original content from: Concept Medical Inc., transmitted by news aktuell