Magic Touch™ sirolimus coated balloon (Concept Medical) versus SeQuent™ paclitaxel coated balloon (BBraun) for the treatment of de novo coronary artery lesions in small coronary vessels
Founder & CEO Concept Medical
• The objective of the study is to compare angiographic outcomes of Magic Touch sirolimus coated balloon (Concept Medical) versus SeQuent Please Neo paclitaxel coated balloon (B.braun) for the treatment of de novo coronary artery lesions in small vessels (≤2.75 mm) with respect to Net Gain (mm) at 6 months follow-up
• A prospective, randomized, multicenter study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.75mm)
•OCT will be performed post pre-dilatation (guidance) prior to DCB treatment
• The DCB balloon size will be selected based on OCT measurements
The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.
Device success (Lesion based); Procedure success; Angiographic outcomes (late lumen loss, minimal lumen diameter, percent diameter stenosis, restenosis rate); Device oriented Composite Endpoint (DoCE / TLF) defined as the composite of cardiac death, TV-MI, and clinically indicated target lesion revascularization (TLR); Acute/subacute/early/late vessel closure/thrombosis.
– Prof. Antonio Colombo
Maria Cecilia Hospital, Cotignola
– Dr. Roberto Nerla
AOU Careggi, Florence
– Prof. Carlo Di Mario
Policlinico San Donato, San Donato
– Prof. Luca Testa
Humanitas Research Hospital IRCSS, Rozzano
-Dr. Bernhard Reimers
Heartlands Hospital, Bordesley Green Birmingham
– Dr. Sandeep Basavarajaiah
NUI Galway, Ireland
– Dr. Faisal Sharif
Concept Medical B.V
Concept Medical Research Pvt. Ltd.
Office 901~903, Trinnity Orion,
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Concept Medical Inc.
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Concept Medical PTE Ltd
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