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Optimal Predilatation Technique for BVS Implantation

2016-10-28 05:53:22 | BioPortfolio

Summary

The purpose of this study is to determine the optimal way of predilatation for BVS implantation.

Description

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Coronary Artery Stenosis

Intervention

Predilatation with non-compliant balloon, Predilatation with scoring balloon (Scoroflex), Predilatation with cutting balloon (Flextome)

Status

Not yet recruiting

Source

Cardiology Center Agel

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-28T05:53:22-0400

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