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Clinical Trial Summary

The presence of a coronary bifurcation complicates percutaneous revascularization. Bifurcation stenting needs to take into account the difference of diameter between proximal and distal vessels and the necessity to limit the side branch obstruction. Provisional stenting techniques with balloon juxtaposition as Kissing Balloon Inflation (KBI) fail to demonstrate a clinical benefits. This is probably explain by the detrimental effect during these technics on the proximal segment with an arterial overstretch. A new sequential technique, named rePOT, demonstrated experimentally a mechanical superiority compared to juxtaposition balloon techniques included KBI. RePOT associates an initial proximal optimizing technique (POT), a side branch inflation and a final POT.

A first clinical study (n=106 patients) confirmed these excellent mechanical results with serial OCT analysis and demonstrated an excellent short term safety. Since 2017, rePOT is recommended in Europe in clinical practice.

This large registry is dedicated to confirm the clinical benefits at long term after bifurcation revascularization with rePOT technique before a large randomise trial.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03550196
Study type Observational
Source Hospices Civils de Lyon
Contact Gérard FINET, Pr
Phone 06 31 20 54 72
Email gerard.finet@univ-lyon1.fr
Status Not yet recruiting
Phase
Start date June 2018
Completion date June 2025

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