Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention
- Conditions
- Left Main Coronary Artery Stenosis
- Interventions
- Other: standardised OCT-guided intervention
- Registration Number
- NCT04248777
- Lead Sponsor
- Institut Mutualiste Montsouris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description left main PCI guided by OCT standardised OCT-guided intervention The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol.
- Primary Outcome Measures
Name Time Method success of the OCT procedure Post PCI / Immediate score Thrombolysis In Myocardial Infarction (TIMI) equal to 3 in all vessels, 50% residual stenosis in the various angiography segments, adequate expansion according to minimum intra stent area \> 80% of the luminal area of the reference segment on Main Vessel and Main Branch.
- Secondary Outcome Measures
Name Time Method incidence of major adverse cardiovascular events 30 days post PCI death, cardiovascular death, stent thrombosis, target vessel revascularization
rate of appropriate wire position 30 days post PCI percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.
rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria. 30 days post PCI percentage of stent expansion according to DOCTORS and ILUMIEN-III
Trial Locations
- Locations (11)
Clinique Saint Augustin
🇫🇷Bordeaux, France
Chu Besancon
🇫🇷Besancon, France
Ch Chartres
🇫🇷Le Coudray, France
Chu Bordeaux
🇫🇷Bordeaux, France
Hôpital privé Saint Martin
🇫🇷Caen, France
Institut hospitalier Jacques Cartier
🇫🇷Massy, France
Clinique Saint Hilaire
🇫🇷Rouen, France
CHU Nîmes
🇫🇷Nîmes, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Chu Clermont Ferrand
🇫🇷Clermont Ferrand, France
Ch Annecy Genevois
🇫🇷Metz-Tessy, France