Concept Medical has announced the enrolment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FOR MagicTouch sirolimus-coated balloon).
TRANSFORM-1 is a prospective, randomised, multicentre, European study focusing on coronary artery lesions in small vessels with a head-on comparison between sirolimus-coated MagicTouch and paclitaxel-coated SeQuent Please NEO (B Braun). In total, 114 patients are planned to be randomised 1:1 for Magic Touch or SeQuent Please NEO. MagicTouch is a CE mark approved and commercially marketed Sirolimus coated balloon, developed using proprietary Nanolute Technology.
The primary objective of the study is to compare angiographic outcomes of the devices, for the treatment of de novo coronary artery lesions in small vessels (≤2.5 mm) with respect to net gain (mm) at six months follow-up. Optical coherence tomography (OCT) will be conducted at baseline. Quantitative coronary angiography (QCA) assessment will be performed at baseline (pre- and post-procedure) and at six months follow-up. Quantitative OCT assessment will be performed at baseline. Clinical follow-up will occur at one, six and 12 months post-percutaneous coronary intervention (PCI).
The study is chaired by Patrick Serruys (National University of Ireland, Galway, Ireland) and Bernardo Cortese (San Carlo Clinic Milano, Milan, Italy) and the principal investigator is Antonio Colombo (Centro Cuore Columbus, Milan, Italy).
The index patient was enrolled at Maria Cecilia Hospital, Cotignola, Italy and underwent a successful PCI procedure on 1 September 2020.
Commenting on the index patient enrolment, Colombo said: “Transform-1 is launching a new standard in drug coated balloon technology; let us enthusiastically make this study move forward.”
Cortese, the chairman of the study, added: “This is great news. We struggled in the last couple of years to have one of the most modern and scientific study design that includes OCT for lesion assessment. We look forward to enrolling all the patients at the earliest by this remarkable group of Investigators.”
Serruys said: “I have to give full credit to Concept Medical and its CEO Manish Doshi for allowing key opinion leaders like Bernardo Cortese, and Antonio Colombo to perform an important mechanistic study based on OCT to diagnose truly small vessels and to attempt to demonstrate in a randomised trial the superior value of the Magic Touch SCB, a DCB technology that uses the powerful hydrophilic sirolimus encapsulated in lipidic microsphere with a deep vessel wall penetration and a long intra parietal residency.”