First patient enrolled in TRANSFORM I RCT

First patient enrolled in TRANSFORM I RCT

Hotline release-T1 on the go

“Well Begun!!! … Index patient enrolled in the crucial Transform -1 RCT using MagicTouch sirolimus coated balloon for small coronary vessels”.

 

Concept Medical Inc., focused on vascular intervention drug delivery devices, has announced the enrolment of the first patient in the TRANSFORM-1 RCT (TReAtmeNt of Small coronary vessels: Randomized controlled trial FORMagicTouch 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. 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 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 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 onSeptember 1, 2020in 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 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 study analysed in the CORRIB Core Lab at the National University of Ireland (NUI Galway) under the leadership of Prof. Yoshi Onuma”.

 

About MagicTouch:

MagicTouch is a CE approved and commercially marketed Sirolimus coated balloon, developed using proprietary Nanolute Technology. MagicTouch has been deployed in >50,000 patients in major global markets. Nanolute – the unique drug delivery technology platform of MagicTouch 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.

 

About Concept Medical Inc (CMI):

CMI is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore and Brazil and manufacturing units in India. CMI specializes in developing drug-delivery systems and has unique and patented technology platforms that can be deployed to deliver any drug / pharmaceutical agent across the luminal surfaces of blood vessels.

 

 

Piccoleto II: my interview during JIM 2020 on the 1 year outcome of the Piccoleto II study

https://www.radcliffecardiology.com/JIM-2020-PICCOLETO-II-trial-Bernardo-Cortese

1. What was the PICCOLETO II study design and what did it aim to assess?
2. What are the key outcomes and how do they compare to studies such as BASKET-SMALL II?
3. Were there limitations with PICCOLETO II?
4. In your opinion, how should PICCOLETO II influence practice?
5. What questions remain unanswered that require further research?

Sirolimus: my interview during JIM 2020 on the current status of research concerning Sirolimus-coated balloons for coronary use

https://www.radcliffecardiology.com/JIM-2020-Sirolimus-DCB-Bernardo-Cortese

1. Why are Sirolimus DCBs needed as a technology?
2. How does the Sirolimus coating work?
3. What data supports there use in comparison to other DCBs?
4. When are you using DCBs in your practice?
5. What further research is required to validate sirolimus DCBs as the coating of choice?

Is paclitaxel associated with higher mortality? The DCB in periphery conundrum: my perspective

About one year ago, a metanalysis conducted by Dr. Katsanos and Coll. showed an increase in mortality following the use of paclitaxel-coated balloons / stents when used for femoro-popliteal PTA. The whole sector was evidently shocked as a result to this metanalysis, and many actions (some of them absolutely unjustified) have been taken since then.

After one year, after a necessary cooling off period and further analyses, it is time for me to take a clear position on the matter.

Therefore, we are presenting our point of view regarding the topic, as expressed in some published editorials.

Today we are presenting the last one:

“Mortality Increase and Paclitaxil-Coated Device Use” December 2019