Concept Medical announced the use of MagicTouch Siromos-coated balloons to treat key Transform-1 randomized controlled trials of coronary artery small vascular lesions.

Read: Concept Medical Inc., which specializes in vascular interventional dosing devices, announced that transform-1 randomized controlled trials (treating coronary artery small vascular lesions: a randomized controlled trial for MagicTouch Siromos coated balloons) recruited the first patients.
, Italy, September 3, 2020 /XINHUA/ -- Concept Medical Inc., which specializes in vascular interventional dosing devices, announced that TRANSFORM-1 randomized controlled trials (treatment of coronary artery small vascular lesions: a randomized controlled trial for Magic Toch seromos coated balloons) recruited the first patient.
TReAtmeNt of Small coronary vessels: Randomized controled trial for MagicTouch sirolimus coated balloon. TRANSFORM-1 is a forward-looking, randomized, multi-center European study focused on coronary artery small vascular lesions and directly compared between Siromos-coated Magic Touch and yew alcohol-coated B. Braun's next-generation drug balloon, SeQuent Please NEO.
114 patients will be randomly treated with MagicTouch or a new generation of drug balloons on a 1:1 scale as planned.
The main objective of this study was to compare net growth results (in millimeters) through angiosis over a six-month follow-up of coronary arterial small angiopathy (no more than 2.5 mm in diameter) that had not been treated by angiomorphic surgery/stent prior to the new treatment of MagicTouch Siromos coated balloons and new-generation drug balloons.
optically relevant fault scan (OCT) will be performed at the baseline.
quantitative coronary angiosis (QCA) assessment will be performed in baseline states (before and after surgery) and during 6 months of follow-up.
quantitative QCT assessment will also be performed at the baseline state.
follow-up will be conducted 1 month, 6 months and 12 months after the coronary artery intervention therapy (PCI).
the study was led by Professor Patrick Serruys of Ireland and Dr Bernardo Curtis of Italy, and was led by Professor Antonio Colombo of Italy.
patient was recruited at Maria Cecilia Hospital in Cotignola, Italy, and under the care of lead researcher Professor Antonio Columb, he underwent PCI surgery in Italy on September 1, 2020.
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