Coronary Revascularisation by rePOT

NCT ID: NCT03550196

Last Updated: 2024-04-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-14
• Study Completion Date: 2022-06-23

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.

Conditions

Coronary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , France

Countries

France

Other Identifiers

69HCL17_0877

Identifier Type: -

Identifier Source: org_study_id