Concept Medical announces enrolment of index patient in the crucial Transform -1 RCT using MagicTouch sirolimus coated balloon for small coronary vessels

PR85378

COTIGNOLA, Italy, Sept. 3, 2020 /PRNewswire=KYODO JBN/ --

Concept Medical Inc.,[ https://www.conceptmedical.com/ ] focused on vascular

intervention drug delivery devices, has announced the enrolment of the first

patient in the TRANSFORM-1 [https://www.conceptmedical.com/press-release/well-begun-index-patient-enrolled-in-the-crucial-transform-1-rct-using-magictouch-sirolimus-coated-balloon-for-small-coronary-vessels/ ] RCT (TReAtmeNt of Small coronary vessels:

Randomized controlled trial FOR MagicTouch sirolimus coated balloon).

TRANSFORM-1 [ https://www.conceptmedical.com/clinical-program/transform-i/   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. 114

patients are planned to be randomized 1:1 for Magic Touch or SeQuent Please NEO.

The primary objective of the study is to compare angiographic outcomes of

MagicTouch [ https://www.conceptmedical.com/product/magic-touch/ ] sirolimus

coated balloon with SeQuent Please NEO, for the treatment of de-novo coronary

artery lesions in small vessels (less than or equal to 2.5 mm) with respect to

Net Gain (mm) at 6 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 1, 6 and 12 months post-PCI.

The study is chaired by Prof. Patrick Serruys, Ireland and Dr. Bernardo Cortese,

Italy and the principal investigator is Prof. Antonio Colombo from Italy.

The index patient was enrolled at Maria Cecilia Hospital, Cotignola, Italy and

went through successful PCI procedure on September 1, 2020 in Italy under the

care of PI Prof. Antonio Colombo.

To quote Antonio Colombo on the index patient enrolment, "Transform-1 is

launching a new standard in Drug Coated Balloon technology; let us

enthusiastically make this study move forward.".

Bernardo Cortese, the Chairman of the study was equally elated and remarked,

"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."

Patrick Serruys, Professor of Interventional Medicine & Innovation, National

University of Ireland, Galway was all praise, "I have to give full credit to

Concept Medical [ http://www.conceptmedical.com/ ] 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 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

[https://www.conceptmedical.com/clinical-program/transform-i/ ] study analysed

in the CORRIB Core Lab at the National University of Ireland (NUI Galway) under

the leadership of Prof. Yoshi Onuma".

www.conceptmedical.com 

Photo - https://mma.prnewswire.com/media/1247888/Transform_1.jpg 

Logo - https://mma.prnewswire.com/media/1244676/Concept_Medical_Logo.jpg 

SOURCE: Concept Medical