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

Left Main Coronary Artery Stenosis Clinical Trial

— LEMON  

Official title:

LEft Main Oct Guided iNterventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248777
• Other study ID #: CARDIO-2017-01
• Status: Completed
• Phase: N/A
• Start date: May 18, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: January 2020
• Source: Institut Mutualiste Montsouris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 1, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Stenosis
• Left Main Coronary Artery Stenosis

Intervention

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.

Locations

Country	Name	City	State
France	Chu Besancon	Besancon
France	Chu Bordeaux	Bordeaux
France	Clinique Saint Augustin	Bordeaux
France	Hôpital privé Saint Martin	Caen
France	Chu Clermont Ferrand	Clermont Ferrand
France	Ch Chartres	Le Coudray
France	Institut hospitalier Jacques Cartier	Massy
France	Ch Annecy Genevois	Metz-Tessy
France	CHU Nîmes	Nîmes
France	Institut Mutualiste Montsouris	Paris
France	Clinique Saint Hilaire	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	incidence of major adverse cardiovascular events	death, cardiovascular death, stent thrombosis, target vessel revascularization	30 days post PCI
Secondary	rate of appropriate wire position	percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.	30 days post PCI
Secondary	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