PR94313

MILANO, Italy, January 28, 2022 /PRNewswire=KYODO JBN/ -

    FONDAZIONE Ricerca e Innovazione

Cardiovascolare, Milano, focused on cardiovascular research, reports the first

patient enrolment of the TRANSFORM II

[https://www.conceptmedical.com/press-release/transform-ii/] Randomized

Controlled Trial (Sirolimus-coated Balloon Versus Drug-eluting Stent in Native

Coronary Vessels) setting in motion a crucial trial in the Native Coronary

Vessel Treatment domain.

    TRANSFORM II RCT, determined to explore and evaluate the treatment options

in

native coronary vessels, enrolled the index patient on the 16th December 2021 at

Sandro Pertini Hospital, Rome, by the team of Dr. Alessandro Sciahbasi.

    The International, multicentric, prospective, investigator-driven,

open-label

randomized trial will observe and evaluate the efficacy of the Magic Touch

[https://www.conceptmedical.com/product/magic-touch/] Sirolimus Coated Balloon

(Concept Medical Inc. [https://www.conceptmedical.com/]) in a head-to-head

comparison with Everolimus Eluting Stent (EES) considered to be a gold standard

treatment, in 1:1 randomization in the native coronary vessels. This trial is

led by Study Chairman, Dr. Bernardo Cortese of the San Carlo Clinic, Paderno

Dugnano-Milano, Italy. Alongside him in the steering committee are, Dr. Roxana

Mehran, Dr. Alexandre Abizaid, Dr. Stefano Rigattieri, Dr. Fernando Alfonso, Dr.

Jose Maria de la Torre Hernandez and Dr. Peter Smith.

    The idea of intervention in small or mid-sized de-novo coronary lesion with

a

stent is neither desirable nor efficient, considering the heavy metal

scaffolding of the vessel. Newer generation of interventionalists tend to be

hesitant to load the vessel with a metal scaffold in this setting. Drug Coated

Balloons (DCB) therefore offer a better option while treating native coronary

artery lesions.

    A total of 1325 patients will be enrolled. The study population will

consist of

patients with age >18 years with clinical indication of a native vessel PCI

eligibility (stable CAD or Acute coronary syndrome). Native coronary artery

lesion in a vessel with diameter >2.0 mm and <=3.0 mm will be included with a

maximum lesion length of 40 mm (an achievement for this type of trial) further

randomized for intervention with Magic Touch or EES.

    The trial aims to evaluate Magic Touch

[https://www.conceptmedical.com/product/magic-touch/] versus EES with the

primary endpoint of non-inferiority in target lesion failure (TLF), a composite

of cardiac death, ischemia-driven target-lesion revascularization (TLR) and,

target vessel myocardial infarction (MI), at 12 months. The trial will also go

on to verify and measure superiority of the study device in terms of net adverse

clinical events (NACE), a composite of all-cause death, MI, ischemic stroke, and

major bleeding (BARC - 3 or 5) as a co-primary end point. Follow up will be

conducted at 6 months and yearly for 5 years. An OCT sub-study will be performed

in a total of 70 patients, which will receive 9-month angio+OCT follow-up with

Core-Lab analysis.

    Over the years, Drug Eluting Stents

[https://www.conceptmedical.com/product/abluminus-des/] have been the preferred

option in native vessels, however, with newer and advanced DCB technologies,

operators now have access to an alternative without having to worry about metal

in such vessels and can achieve good results. The ongoing TRANSFORM 1

[https://transform1trial.com/] RCT comparing Sirolimus and Paclitaxel DCB in

small coronary vessels: Magic Touch (Concept Medical Inc) and SeQuent Please NEO

(B. Braun) is rapidly progressing with >50% enrollment already done and

TRANSFORM II [https://www.conceptmedical.com/press-release/transform-ii/] that

follows is the perfect RCT to seek further answers in native coronary vessel

treatment.

    Dr. Bernardo Cortese is optimistic and excited with the onset of the RCT and

briefly explains why this is a much-needed trial and what is expected out of it,

"We do not need to expect a stent-like result when we use a DCB; what we aim to,

is to have similar results to DES, and possibly an improved result on the long

term, since we do not implant metal, and metal from stents is associated with a

small but continuous increase in adverse events year-on-year," Dr. Cortese

quotes "Regarding DCB, at least when you use a reliable device, we have observed

a flattening of the events curve after 18 months, so why not expect better

results after 3-4 years?"

    In essence, TRANSFORM II will bring to light the data suggesting why this

transition from stents to balloons is a necessity for some native coronary

vessels and hopefully in the near future, the data will reveal encouraging and

promising results.

    Magic Touch Sirolimus Coated Balloon

[https://www.conceptmedical.com/product/magic-touch/] has already received a

breakthrough device designation from the US FDA for the treatment of small

coronary vessels as well as In-Stent restenosis. This trial may give the

required inclination towards the use of DCB like the Magic Touch. It may

indicate that it is time to transform.

    About Magic Touch:

    Magic Touch is a CE approved and commercially marketed Sirolimus coated

balloon

by Concept Medical, developed using the proprietary Nanolute Technology

[https://www.conceptmedical.com/technology/nanolute/]. Magic Touch has been

deployed in >50,000 patients in major global markets. Nanolute - the unique drug

delivery technology platform of Magic Touch balloon, is designed to deliver

sub-micron particles of Sirolimus which are then encapsulated in a biocompatible

drug carrier. The carrier-complex is designed to reach the deepest layers of the

vessel walls.

    Photo: https://mma.prnewswire.com/media/1736044/TRANSFORM_II_RCT.jpg

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

    Source: Concept Medical Inc.