Concept Medical Inc. - Best Heart Care Institute in Surat
Press Digest

 

CONCEPT MEDICAL announces initiation of global RCT; TRANSFORM II

Dr. Bernardo Cortese is the Principal Investigator with Dr. Alexandra Abizaid as Co-Chairman for TRANSFORM II Randomized Clinical Trial which will be conducted between MagicTouch and Everolimus Eluting Stent in small coronary vessel.

SURAT, India: Concept Medical has planned to start of new Randomized Controlled Trial involving MagicTouch, an only CE certified Sirolimus Drug Coated Balloon, a product of Nanolute technology which is indicated in In-Stent Restenosis, Small Vessels and Bifurcation lesions.

About TRANSFORM II

TRANSFORM II is an International, multicenter, spontaneous randomized clinical trial of MagicTouch (Sirolimus Coated Balloon) versus Everolimus Eluting Stent (EES) in small coronary vessel. The purpose of this study is to observe and evaluate the efficacy of SCB compared to the treatment for native vessel disease, namely with new generation EES. Given the inherent limitations of stents in small coronary arteries, this study constitutes only patients with small coronary vessels (≤2.75 mm diameter by visual estimation) will be enrolled.

The primary endpoint is the non-inferiority of SCB versus DES in terms of in-lesion late lumen loss (LLL) at a 6 months’ angiographic follow-up. The secondary endpoints are the Procedural success, defined as technical and angiographic success (final stenosis <50% in the absence of MACE {Major Adverse Cardiac Event} during hospitalization); Percent diameter stenosis and the occurrence of binary restenosis at 6 months angiographic follow up and MACE (as a composite of cardiac death, myocardial infarction and target lesion revascularization) at 6, 12, 24 and 36 months.

Optical Coherence Technology

The trial has OCT endpoints which considers Acute mean and minimum lumen Cross-Sectional Area (CSA) gain between pre and post-PCI in the SCB and DES groups; Late mean and minimum lumen CSA loss from post-PCI to 6 months and change in lumen area stenosis across all time points (pre-PCI, post-PCI, and 6 months). A series of detailed analysis aiming to evaluate the extension and severity of balloon and stent-induced vascular injury will also be performed. The OCT images will be acquired in a subgroup of 20 patients pre and post-procedure, and at the 6-month angiographic follow-up.

There will be enrolment of 190 patients over a period of 6 months at their respective centers after the authorization from the Institutional Ethics Committees with a follow-up at 30 days, 6 months, 12 months, 24 months and 36 months.  There will be angiographic follow-up at 6 months.

About MagicTouch

MagicTouch, a novel Sirolimus Drug Coated Balloon catheter is a product of a patent Nanolute technology.  The technology is applied to coat drug on the balloon which results for the better bioavailability and retention of the drug. The diffusion of the drug is to the innermost adventitia layer by breaking the molecules in the nano form; making it as a reservoir and gets back to the lumen when required. A biocompatible phospholipid carrier which mimics the body lipid. The uniform coating in the inflated position is applied.

“Very interesting solution for complex anatomical situations” explained Dr. Alexandra Abizaid, (Chief of Coronary Interventions, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil)

About Concept Medical

Concept Medical is an India based intellectual properties driven company, involved in research, development and manufacturing of innovative products and methods for treatment of cardiovascular disease. It is company pioneering in the development of Nanotechnology based applications for drug delivery. It has developed a novel polymer free nano-carrier based drug delivery system in R&D.

References:

https://www.youtube.com/watch?v=2exeirIRCwQ

Source: Concept Medical

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