Concept Medical Announces First Patient Enrolled in TRANSFORM-1 Randomized Controlled Trial Evaluating MagicTouch Sirolimus-Coated Balloon for Coronary Small Vessel Disease

Cotignola, Italy, Sept. 3, 2020 /PRNewswire/ -- Focused on vascular interventional drug delivery devicesConcept Medical Inc. Announced,TRANSFORM-1Randomized Controlled Trial (Treatment of Coronary Small Vessel Disease: A Randomized Controlled Trial of the MagicTouch Sirolimus-Coated Balloon) Enrolls First Patient.

TRANSFORM-1This is a prospective, randomized, multicenter European study primarily focusing on coronary small vessel disease, with a direct comparison between the sirolimus-coated MagicTouch and the paclitaxel-coated next-generation drug-coated balloon SeQuent Please NEO from B. Braun (Germany). A total of 114 patients will be randomly assigned in a 1:1 ratio to receive treatment with either MagicTouch or the next-generation drug-coated balloon SeQuent Please NEO.

The primary objective of this study is toMagicTouchIn the 6-month follow-up after treatment of de novo coronary small vessel disease (diameter ≤2.5 mm) with sirolimus-coated balloons and the next-generation drug-coated balloon Neopac, angiographic comparison of net lumen gain (in millimeters) will be performed. Optical coherence tomography (OCT) will be conducted at baseline. Quantitative coronary angiography (QCA) assessments will be performed at baseline (pre- and post-procedure) and at the 6-month follow-up. Quantitative computed tomography (QCT) assessments will also be performed at baseline. Clinical follow-up will be conducted at 1 month, 6 months, and 12 months after percutaneous coronary intervention (PCI).

This study was conducted by Patrick Serris from Ireland (Patrick Serruys) Professor and Dr. Bernardo Cortese from Italy presided, with the principal investigator being Antonio Colombo from Italy (Antonio Colombo) Professor.

The index patient was recruited at Maria Cecilia Hospital in Cotignola, Italy. On September 1, 2020, under the supervision of Principal Investigator Professor Antonio Colombo, the patient successfully underwent percutaneous coronary intervention (PCI) in Italy.

Antonio Colombo stated regarding the recruitment of index patients:“Transform-1 has set a new standard in drug-coated balloon technology, enabling us to advance this research with great enthusiasm.”

Bernardo-Curtis, the principal investigator, was also delighted and stated:“This is good news. We have worked hard over the past few years and obtained the most modern, the most scientifically rigorous study design, and ensure that this design covers lesion assessment-orientedOCT. We hope that our distinguished group of researchers will be able to enroll all patients as soon as possible.”

University of Galway (National UniversityPatrick Serrys, Professor of Interventional Medicine and Innovation at the University of Galway, Ireland, spoke highly of the enrollment of index patients, stating:"I had toConcept Medicaland its CEO, Manish Doshi (Manish Doshi) fully affirmed, they let likeBernardo- Key opinion leaders such as Curtis and Antonio Colombo are able to conduct important mechanistic studies based on OCT, accurately diagnose true small vessel disease, and attempt to demonstrate the exceptional value of the MagicTouch Sirolimus-Coated Balloon in randomized trials. The MagicTouch Sirolimus-Coated Balloon is a drug-coated balloon technology that utilizes potent hydrophilic sirolimus encapsulated in lipid microspheres, enabling deep penetration into the vessel wall and prolonged retention within it. Many studies on small vessels have in fact been mislabeled, because the precise vessel diameter was not carefully documented as we have done. We willTRANSFORM 1In the study, OCT was utilized for this analysis. Under the leadership of Professor Yoshi Onuma, this study will be conducted atCore Laboratory, University of Galwayproceed.”

Website:www.conceptmedical.com