Much awaited, much needed: TRANSFORM II Randomized Controlled Trial by Fondazione RIC gets rolling

Milano (Italy) [India], January 28 (ANI/PR Newswire): FONDAZIONE Ricerca e Innovazione Cardiovascolare, Milano, focused on cardiovascular research, reports the first patient enrolment of the (https://www.conceptmedical.com/press-release/transform-ii) TRANSFORM II Randomized Controlled Trial (Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels) setting in motion a crucial trial in the Native Coronary Vessel Treatment domain.

TRANSFORM II RCT, determined to explore and evaluate the treatment options in native coronary vessels, enrolled the index patient on the 16 December 2021 at Sandro Pertini Hospital, Rome, by the team of Dr Alessandro Sciahbasi.

The International, multicentric, prospective, investigator-driven, open-label randomized trial will observe and evaluate the efficacy of the (https://www.conceptmedical.com/product/magic-touch) Magic Touch Sirolimus Coated Balloon (https://www.conceptmedical.com) Concept Medical Inc.) in a head-to-head comparison with Everolimus-Eluting Stent (EES) considered to be a gold standard treatment, in 1:1 randomization in the native coronary vessels. This trial is led by Study Chairman, Dr Bernardo Cortese of the San Carlo Clinic, Paderno Dugnano-Milano, Italy. Alongside him in the steering committee are Dr Roxana Mehran, Dr Alexandre Abizaid, Dr Stefano Rigattieri, Dr Fernando Alfonso, Dr Jose Maria de la Torre Hernandez and Dr Peter Smith.

The idea of intervention in small or mid-sized de-novo coronary lesion with a stent is neither desirable nor efficient, considering the heavy metal scaffolding of the vessel. Newer generation of interventionalists tend to be hesitant to load the vessel with a metal scaffold in this setting. Drug-Coated Balloons (DCB) therefore offer a better option while treating native coronary artery lesions.

A total of 1325 patients will be enrolled. The study population will consist of patients with age & gt;18 years with clinical indication of a native vessel PCI eligibility (stable CAD or Acute coronary syndrome). Native coronary artery lesion in a vessel with diameter & gt;2.0 mm and