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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| left main PCI guided by OCT | Other | The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardised OCT-guided intervention | Other | The first OCT run (run1) analyse plaque characteristics, identify proximal and distal landing zones (according to previously published criteria) , measure lesion length and reference segments dimensions (diameters and luminal areas). The second run (run2) aims to assess adequate guidewire recrossing point into stent jailed side branch and identify early stent mechanical non-optimal results. The third run (run3) analyse final stent expansion and identify major struts malposition and edge dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| success of the OCT procedure | 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. | Post PCI / Immediate |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of major adverse cardiovascular events | death, cardiovascular death, stent thrombosis, target vessel revascularization | 30 days post PCI |
| rate of appropriate wire position | percentage of appropriate wire position in adequate stent cell before side branch ostium dilation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas AMABILE, MD,PhD | Institut Mutualiste Montsouris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Besancon | Besançon | 25030 | France | |||
| Chu Bordeaux |
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Patients with left main artery planned PCI for stable or unstable coronary artery disease.
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|
| 30 days post PCI |
| rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria. | percentage of stent expansion according to DOCTORS and ILUMIEN-III | 30 days post PCI |
| Bordeaux |
| 33000 |
| France |
| Clinique Saint Augustin | Bordeaux | 33200 | France |
| Hôpital privé Saint Martin | Caen | 14050 | France |
| Chu Clermont Ferrand | Clermont-Ferrand | 63000 | France |
| Ch Chartres | Le Coudray | 28630 | France |
| Institut hospitalier Jacques Cartier | Massy | 91300 | France |
| Ch Annecy Genevois | Metz-Tessy | 74370 | France |
| CHU Nîmes | Nîmes | 30900 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Clinique Saint Hilaire | Rouen | 76000 | France |