Coronary Revascularisation by rePOT

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Département de cardiologie Clinique Axium, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Discovery, during angiography, of a significant coronary lesion (by angiographic or functional assessment) including a bifurcation under a provisional stenting strategy. Bifurcation have to be significant according to the operator and the coronary anatomy (but the side branch diameter have to be greater than 1.75mm)
Stable lesion without high thrombus burden
Patient agreement to study participation and ≥ 18 years

Exclusion criteria

Complex lesion or anatomy requiring revascularization strategy with more than one stent
Contraindication to a double platelet anti-aggregation ≥ 6mois (recommended implantation of active stent)
Unstable patient according to the operator (used of hemodynamic drug support, mechanical ventilation)
Indication of cardiac surgery.
Lesion culprit in ST- or non ST-elevation myocardial infarction <12h.
High thrombus burden in angiography or endocoronary imaging (IVUS, OCT).
Pregnancy, loose of legal right
Other interventional study participation <30 jours.

Treatment and study plan

Provisional stenting with rePOT technique

Other

All revascularizations have to be performed with complete rePOT technique: initial POT + side branch inflation + final POT. Compliant or semi compliant balloon have to be preferred to inflations. The POT balloon positioning have to be precise as obtain the loose of the parallelism just at the carina cut plan. The rest of the medication or procedure characteristics stay at the discretion of the operator.

The follow-up will be clinic every years.

Primary outcomes

Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.

Time frame: At 12 months

Number of deaths
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.

Time frame: At 12 months

Number of myocardial infections
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.

Time frame: At 12 months

Number of stent thrombosis
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.

Time frame: At 12 months

Number of target lesion revascularization

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Coronary Artery Bifurcation Revascularization Without kIssing ballOon infLation by rEpoT: The CABRIOLET Study

Acronym: CABRIOLET

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jun 8, 2018
Registry last updated: Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed