News List

Sep 11, 2020

Cotignola, Italy, September 3, 2020 - Concept Medical Inc., which focuses on vascular interventional drug delivery devices, announced the TRANSFORM-1 Randomized Controlled Trial (Treatment of Coronary Artery Small Vessel Disease: For MagicTouch Sirolimus Coating Randomized controlled trials of balloons) recruit the first patient.

TRANSFORM-1 is a prospective randomized multi-center European study that focuses on coronary small vessel disease, and uses sirolimus-coated MagicTouch and paclitaxel-coated B. Braun new-generation drug balloons Direct comparison between SeQuent Please NEO. 114 patients will be randomized to receive MagicTouch or new-generation drug balloon treatment at a 1:1 ratio as planned.

The main goal of this study is to treat small coronary artery lesions (no more than 2.5 mm in diameter) that have not been treated with angioplasty/stent before MagicTouch sirolimus-coated balloon and new-generation drug balloon Xinpuchang At the 6-month follow-up, the net growth results (in millimeters) were compared by angiography. Optical coherence tomography (OCT) will be performed under baseline conditions. Quantitative coronary angiography (QCA) assessment will be performed at baseline (before and after surgery) and at the 6-month follow-up. Quantitative QCT assessment will also be performed under baseline conditions. Clinical follow-up will be carried out 1 month, 6 months and 12 months after percutaneous coronary intervention (PCI).

The research was led by Professor Patrick Serruys from Ireland and Dr. Bernardo Cortese from Italy. The main researcher was Antonio Colombo from Italy. professor.

The index patient was recruited at Maria Cecilia Hospital in Cotignola, Italy. On September 1, 2020, under the care of the principal investigator, Professor Antonio Columbus, the patient was in Italy Successfully received PCI surgery.