NCT04248777

Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention

LEft Main Oct Guided iNterventions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Institut Mutualiste Montsouris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Left Main Coronary Artery Stenosis

Interventions

Type	Name	Description
OTHER	standardised OCT-guided intervention	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.

Timeline

• Start date: 2018-05-18
• Primary completion: 2019-01-28
• Completion: 2019-02-01
• First posted: 2020-01-30
• Last updated: 2020-01-30

Locations

11 sites across 1 country: France