Clinical trial NCT04248777: Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention
Official title: LEft Main Oct Guided iNterventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Main Coronary Artery Stenosis
Keywords: Optical Coherence Tomography (OCT)
Percutaneous Coronary Intervention (PCI).
Lead sponsor: Institut Mutualiste Montsouris
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with left main artery planned PCI for stable or unstable coronary artery disease.
Primary purpose: OTHER

Brief summary: LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).

Detailed description: The LEMON study (LEft Main Oct-guided iNterventions) is a prospective, multicentre, open-label, interventional , non-randomized trial that investigates the feasibility and efficiency of OCT guidance for left main PCI in 10 active French interventional cardiology centres. The aim of the study is the appliance of a pre-defined standardized protocol for LM PCI . The LM PCI strategy is guided by 3 OCT runs, according to a pre-determined protocol. The first OCT run (run1) is performed before any stent implantation, the second run (run2) is performed after the stent is implanted, POT (proximal optimization technique) is applied and side branch iss rewired through stent struts. The third run (run3) is performed after PCI optimization. In case of additional stent optimization, a supplementary OCT run is applied in order to assess final result.

Eligibility criteria: Inclusion Criteria:

* age \>18
* stable or non-stable distal Left Main lesion (with or without previous Coronary Artery Bypass Graft), involving or not Left Anterior Descending and Coronary Circumflex ostias and requiring Percutaneous Coronary Intervention with a one or two stents strategy
* stable or non-stable ostial Left Anterior Descending and/or Coronary Circumflex lesion requiring Percutaneous Coronary Intervention with involvement of distal Left Main
* SYNTAX angiographic score \<23
* informed consent

Exclusion Criteria:

* ostial Left Main lesion
* on-going acute STEMI
* on-going cardiogenic shock
* severe chronic renal failure (Cr Cl \<30 ml/min/m2)
* anticipated technical contra-indication to OCT (highly calcified lesions, severe proximal tortuosity)

Primary outcomes:
measure: success of the OCT procedure
timeFrame: Post PCI / Immediate
Secondary outcomes:
measure: incidence of major adverse cardiovascular events
timeFrame: 30 days post PCI
measure: rate of appropriate wire position
timeFrame: 30 days post PCI
measure: rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.
timeFrame: 30 days post PCI
Other outcomes:
Locations:
city: Besancon
country: France
facility: Chu Besancon
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Caen
country: France
facility: Hôpital privé Saint Martin
city: Clermont Ferrand
country: France
facility: Chu Clermont Ferrand
city: Le Coudray
country: France
facility: Ch Chartres
city: Massy
country: France
facility: Institut hospitalier Jacques Cartier
city: Metz-Tessy
country: France
facility: Ch Annecy Genevois
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Rouen
country: France
facility: Clinique Saint Hilaire
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Nicolas AMABILE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: