Left Main Coronary Artery StenosisLEMONNCT04248777
Optical Coherence Tomography - Guided Protocol for Left Main Percutaneous Coronary Intervention
A study testing standardised OCT-guided intervention in people with Left Main Coronary Artery Stenosis, run by Institut Mutualiste Montsouris at 11 sites in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Main Coronary Artery Stenosis
- What is being tested?
- standardised OCT-guided intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 11 sitesFrance
- Study dates
- 18 May 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Chu Besancon
Besançon, 25030
Chu Bordeaux
Bordeaux, 33000
Clinique Saint Augustin
Bordeaux, 33200
Hôpital privé Saint Martin
Caen, 14050
Chu Clermont Ferrand
Clermont-Ferrand, 63000
Ch Chartres
Le Coudray, 28630
Institut hospitalier Jacques Cartier
Massy, 91300
Ch Annecy Genevois
Metz-Tessy, 74370
CHU Nîmes
Nîmes, 30900
Institut Mutualiste Montsouris
Paris, 75014
Clinique Saint Hilaire
Rouen, 76000
About this study
Official title: LEft Main Oct Guided iNterventions
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).
Read the 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
- Being tested
- standardised OCT-guided intervention
- Keywords
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardised OCT-guided interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| left main PCI guided by OCT | Other | The LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol. Receives: Other: standardised OCT-guided intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post PCI / Immediate
Secondary outcomes (3)
incidence of major adverse cardiovascular events
death, cardiovascular death, stent thrombosis, target vessel revascularization
Measured: 30 days post PCI
rate of appropriate wire position
percentage of appropriate wire position in adequate stent cell before side branch ostium dilation.
Measured: 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
Measured: 30 days post PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start18 May 2018
- Primary completion28 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Main Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with left main artery planned PCI for stable or unstable coronary artery disease.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas AMABILE, MD,PhD, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248777
- Sponsor's protocol ID
- CARDIO-2017-01
- Acronym
- LEMON
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEft Main Oct Guided iNterventions
- ClinicalTrials.gov ID
- NCT04248777
- Acronym / sponsor ID
- LEMON / CARDIO-2017-01
- Conditions
- Left Main Coronary Artery Stenosis
- Keywords
- Optical Coherence Tomography (OCT), Percutaneous Coronary Intervention (PCI).
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 18 May 2018 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with left main artery planned PCI for stable or unstable coronary artery disease.
| Arm | Type | Receives |
|---|---|---|
| left main PCI guided by OCT | Other | Other: standardised OCT-guided interventionThe LM PCI strategy is guided by 3 OCT runs, according to a pre-defined standardized protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardised OCT-guided interventionThe 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. | Other | left main PCI guided by OCT |
Primary outcome
success of the OCT procedure
Time frame: 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.
3 secondary outcomes
incidence of major adverse cardiovascular events
Time frame: 30 days post PCI
rate of appropriate wire position
Time frame: 30 days post PCI
rate of appropriate stent expansion according to DOCTORS and ILUMIEN-III criteria.
Time frame: 30 days post PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Left Main Coronary Artery Stenosis
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ANGiographic Evaluation of Left Main Coronary Artery INtErvention
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Crossover vs Accurate Ostial PCI for Medina 0.0.1 and 0.1.0 Left Main Bifurcation Lesions
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Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM)
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Not yet recruiting
COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.
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RecruitingObservational study
µQFR for Branch Stenosis After Single Stent in Bifurcation Lesions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas AMABILE, MD,PhD principal investigator
Institut Mutualiste Montsouris
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardised OCT-guided intervention in people with Left Main Coronary Artery Stenosis, run by Institut Mutualiste Montsouris at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success of the OCT procedure (time frame: Post PCI / Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.