Coronary Revascularisation by rePOT

NCT03550196 | Completed

• 1 other identifier: 69HCL17_0877
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

Provisional stenting with rePOT technique OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Département de cardiologie Clinique Axium

Aix-en-Provence, 13090, France

Location

Fédération de cardiologie médicale - Hôpital Cardiologique Louis Pradel - Hospices civils de Lyon

Bron, 69500, France

Location

Département de cardiologie Hôpital Gabriel Montpied CHU de Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

Département de cardiologie CHU de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 8, 2018
• Study Start: May 14, 2018
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)