Coronary Revascularisation by rePOT

Coronary Disease Clinical Trial

— CABRIOLET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03550196
• Other study ID #: 69HCL17_0877
• Status: Completed
• Start date: May 14, 2018
• Est. completion date: June 23, 2022

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Other:
• Provisional stenting with rePOT technique
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.

Locations

Country	Name	City	State
France	Département de cardiologie Clinique Axium	Aix-en-Provence
France	Fédération de cardiologie médicale - Hôpital Cardiologique Louis Pradel - Hospices civils de Lyon	Bron
France	Département de cardiologie Hôpital Gabriel Montpied CHU de Clermont Ferrand	Clermont-Ferrand
France	Département de cardiologie CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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