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Clinical Trial Summary

The study is a prospective, multinational (Italy and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) 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

Clinical Trial Description

A prospective, randomized, multi-centre study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.5mm). Vessel size will be determined first by QCA on-line (screening, pre-procedure). If, based on QCA on-line the vessel size pre-procedure is ≤2.5mm and following a successful pre-dilatation (i.e. no angiographic dissections type CDEF and TIMI>2), the subject will be randomized in a 1:1 fashion to Magic Touch or SeQuent Please Neo. OCT will be performed post pre-dilatation (guidance) prior to drug coated balloon (DCB) treatment. The DCB balloon size will be selected based on OCT measurements. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03913832
Study type Interventional
Source Concept Medicals BV
Status Not yet recruiting
Phase N/A
Start date May 2019
Completion date December 2020

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