Clinical trial NCT03550196: Coronary Revascularisation by rePOT
Official title: Coronary Artery Bifurcation Revascularization Without kIssing ballOon infLation by rEpoT: The CABRIOLET Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patient with stable coronary lesion interesting a bifurcation with indication of revascularization (angiographique or functional) by provisional stenting technique can be included.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
timeFrame: At 12 months
measure: Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
timeFrame: At 12 months
measure: Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
timeFrame: At 12 months
measure: Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.
timeFrame: At 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Département de cardiologie Clinique Axium
city: Bron
country: France
facility: Fédération de cardiologie médicale - Hôpital Cardiologique Louis Pradel - Hospices civils de Lyon
city: Clermont-Ferrand
country: France
facility: Département de cardiologie Hôpital Gabriel Montpied CHU de Clermont Ferrand
city: Nîmes
country: France
facility: Département de cardiologie CHU de Nimes
Study officials:
References: