Concept Medical Enrolls First Patient in Trial for Sirolimus-Coated Coronary Balloon

Concept Medical Inc., focused on vascular intervention drug delivery devices, has enrolled 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, randomized, multi-center, 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 of B. Braun. One hundred fourteen patients are planned to be randomized one-to-one for Magic Touch or SeQuent Please NEO. 
 
The primary objective of the study is to compare angiographic outcomes of MagicTouch sirolimus-coated balloon with SeQuent Please NEO, 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 6 months follow-up. Quantitative OCT assessment will be performed at baseline. Clinical follow-up will occur at one, six, and 12 months post-PCI.
 
The study is chaired by Prof. Patrick Serruys of Ireland and Dr. Bernardo Cortese of Italy, and the principal investigator is Prof. Antonio Colombo from Italy.

“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 group of Investigators,” said Cortese, study chairman.
 
The index patient was enrolled at Maria Cecilia Hospital, Cotignola, Italy, and went through successful PCI procedure on Sept. 1 under Colombo’s care. “Transform-1 is launching a new standard in drug-coated balloon technology; let us enthusiastically make this study move forward,” Colombo said.
 
Patrick Serruys, professor of Interventional Medicine and Innovation, National University of Ireland, Galway, commented: “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 randomized trial the 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. Many studies on small vessels are in fact misnomers since the precise calibre of the vessel was not carefully documented like we will do with the use of OCT in the TRANSFORM 1 study analyzed in the CORRIB Core Lab at the National University of Ireland (NUI Galway) under the leadership of Prof. Yoshi Onuma.”