Coronary Revascularisation by rePOT

Completed

• Conditions: Coronary Disease

• Registration Number: NCT03550196
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-14
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Primary Completion: 2022-06-23
• Study Completion: 2022-06-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term clinical benefits after revascularization of coronary bifurcations by the technique of provisional stenting rePOT.	At 12 months	Number of target lesion revascularization

Trial Locations

Locations (4)

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 Clinique Axium; 🇫🇷 Aix-en-Provence, France

Département de cardiologie CHU de Nimes; 🇫🇷 Nîmes, France