September 2, 2020
First Patient Enrolled in TRANSFORM-1 RCT of Concept Medical’s MagicTouch Sirolimus-Coated Balloon for Small Coronary Vessels
September 2, 2020—Concept Medical Inc. announced the enrollment of the first patient in the TRANSFORM-1 randomized clinical trial (RCT) of the treatment of small coronary vessels with percutaneous coronary intervention (PCI) using the company’s MagicTouch sirolimus-coated balloon.
The prospective, multicenter, European RCT will compare the MagicTouch sirolimus-coated balloon and the paclitaxel-coated SeQuent Please Neo (B. Braun Interventional Systems, Inc.) in 114 patients, randomized 1:1. The primary objective of the study is to compare angiographic outcomes for the treatment of de novo coronary artery lesions in small vessels (≤ 2.5 mm) with respect to net gain (mm) at 6-month follow-up.
In the study, optical coherence tomography (OCT) will be conducted at baseline. Quantitative coronary angiography assessment will be performed at baseline (pre- and postprocedure) and at 6-month follow-up. Quantitative OCT assessment will be performed at baseline. Clinical follow-up will occur at 1, 6, and 12 months post-PCI.
The study is chaired by Patrick Serruys, MD, and Bernardo Cortese, MD. The Principal Investigator is Antonio Colombo, MD.
Prof. Colombo enrolled the first patient in the trial. The PCI procedure was successfully performed on September 1, 2020, at Maria Cecilia Hospital in Cotignola, Italy.
“TRANSFORM-1 is launching a new standard in drug-coated balloon technology; let us enthusiastically make this study move forward,” commented Prof. Colombo in Concept Medical’s press release.
Also in the company’s announcement, Dr. Cortese stated, “This is great news. We struggled in the last couple of years to have one of the most modern and scientific study designs that includes OCT for lesion assessment. We look forward to enrolling all the patients at the earliest by this remarkable group of Investigators.”
Prof. Serruys added, “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 superior value of the Magic Touch sirolimus-coated balloon, a drug-coated balloon technology that uses the powerful hydrophilic sirolimus encapsulated in lipidic microsphere with a deep vessel wall penetration and a long intraparietal residency.”
He continued, “Many studies on small vessels are, in fact, misnomers since the precise caliber 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, MD.”