NCT03550196

Coronary Revascularisation by rePOT

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-14
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2018-06-08
• Last updated: 2024-04-11

Locations

4 sites across 1 country: France