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NCT03550196: CABRIOLET

Coronary Revascularisation by rePOT

Completed Last updated 11 April 2024
What this trial tests

trial testing Provisional stenting with rePOT technique in Coronary Disease in 500 participants. Completed in 23 June 2022.

Timeline
14 May 2018
Primary endpoint
23 June 2022
23 June 2022

Quick facts

Lead sponsorHospices Civils de Lyon
StatusCompleted
Study typeOBSERVATIONAL
Enrollment500
Start date14 May 2018
Primary completion23 June 2022
Estimated completion23 June 2022
Sites4 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Coronary Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. One year results of coronary bifurcation revascularization with the re-POT provisional sequential technique. The CABRIOLET registry.
    Dérimay F, Aminian A, Lattuca B, Souteyrand G, et al · · 2024 · cited 2× · PMID 38048882 · DOI 10.1016/j.ijcard.2023.131632

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