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The purpose of this study is to determine the optimal way of predilatation for BVS implantation.
Randomized, single-center study. Forty-five patients with intended BVS implantation will be randomized in ratio of 1:1:1 to different predilatation strategies(non-compliant balloon/Emerge NC™, Boston Scientific, cutting balloon/Flexitome™, scoring balloon/Scoroflex™,Orbus). Predilatation is intended to be done in a vessel:balloon ratio of 1:1. If the device is not able enter the lesion, it will be replaced with a conventional semicompliant balloon with the same predilatation strategy (a vessel:balloon ratio of 1:1) After a successful predilatation, the BVS (Absorb™, Abbott) will be implanted and this procedure will be accomplished by a high pressure postdilatation with a non-compliant balloon (Emerge NC™, BSCI). The MLA of the Absorb stent will be evaluated with optical coherence tomography (OPTIS, St.Jude).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
November 1, 2016
Primary Completion Date
March 1, 2017
Completion Date
March 1, 2017
Last Updated
October 27, 2016
45
ESTIMATED participants
Predilatation with non-compliant balloon
DEVICE
Predilatation with scoring balloon (Scoroflex)
DEVICE
Predilatation with cutting balloon (Flextome)
DEVICE
Lead Sponsor
Cardiology Center Agel
NCT05831085
NCT05860400
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