Coronary Revascularisation by rePOT (CABRIOLET)

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Other: Provisional stenting with rePOT technique

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Aix-en-Provence, France, 13090
    • Département de cardiologie Clinique Axium
  • Bron, France, 69500
    • Fédération de cardiologie médicale - Hôpital Cardiologique Louis Pradel - Hospices civils de Lyon
  • Clermont-Ferrand, France, 63003
    • Département de cardiologie Hôpital Gabriel Montpied CHU de Clermont Ferrand
  • Nîmes, France, 30029
    • Département de cardiologie CHU de Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.	Number of deaths	At 12 months
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.	Number of myocardial infections	At 12 months
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.	Number of stent thrombosis	At 12 months
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.	Number of target lesion revascularization	At 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): June 23, 2022

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: 69HCL17_0877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No