Clinical trial NCT04391413: Does OCT Optimise Results of Stenting on the Left Main Stem
Official title: Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Myocardial Ischemia
Non ST Segment Elevation Myocardial Infarction
Keywords: left main stem
angioplasty
optical coherence tomography
myocardial infarction
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The DOCTORS-LM study will investigate the impact of using optical coherence tomography (OCT) to guide the procedure in angioplasty of lesions of the left main stem responsible for myocardial ischemia.

Detailed description: Angiographic evaluation of lesions of the left main stem presents particular challenges and high procedural complexity. The clinical sequelae of a suboptimal result in this context may be severe, and thus, it is recommended that patients with left-main lesions be considered for imaging-guided interventions by means of optimal coherence tomography (OCT) in non-ostial left main lesions. The investigators have previously demonstrated in a randomized trial of patients undergoing PCI for a lesion responsible for non ST elevation acute coronary syndromes that OCT provides useful clinical information beyond that obtained by angiography alone, and OCT-guidance for angioplasty in these patients yielded a significantly higher proportion of patients with an optimal functional result after stenting. In this context, the aim of the present study is to evaluate whether OCT-guided left-main angioplasty is superior to left main angioplasty guided by fluoroscopy alone, as assessed by fractional flow reserve (FFR) measured after stent implantation. Eligible patients must be aged 18 years and over, admitted for acute coronary syndrome (ACS) or stable coronary artery disease (CAD); AND present an angiographically significant non-ostial lesion of the left main stem requiring angioplasty with drug eluting stent implantation.

Eligibility criteria: Inclusion Criteria:

Patients aged 18 years or over presenting with:

* NSTEMI or unstable angina or stable angina or documented silent ischemia AND
* De novo angiographic lesion (% diameter stenosis \>=50%) or functionally significant (FFR\<=0.80) lesion of the left main stem (median or distal) with or without lesions of the ostia of the LAD and/or circumflex arteries (= Medina classification 1-0-0, 1-0-1, 1-1-0, 1-1-1) or ostial lesion of the LAD and/or circumflex artery requiring angioplasty with stent implantation that will cover the distal left main stem (=Medina classification 0-0-1, 0-1-0 ou 0-1-1) AND
* SYNTAX score ≤ 22 (or \>22 and ≤32 and validated by the Heart Team)
* Lesion with reference angiographic diameter \<=5.5mm
* Signature of written informed consent form.

Exclusion Criteria:

Patients with:

* ST segment elevation myocardial infarction
* Ostial lesion of the left main stem
* Technically impossible to perform OCT
* Creatinine clearance ≤ 30 ml/min/1.73m²
* Left ventricular ejection fraction \<30%
* Hypotension or cardiogenic shock
* Unstable ventricular arrhythmia
* Contraindication to dual antiplatelet therapy for at least 6 (or 12) months (duration depending on the initial clinical presentation). Shorter dual antiplatelet therapy is possible in patients with long-term anticoagulation.
* Hypersensitivity or contraindication to any of the antithrombotic therapies used during or after the procedure
* Life expectancy \<1 year
* Persons under judicial protection
* Subjects with no social security coverage
* Anticipated non-compliance with the study procedures
* Pregnant or lactating women
* Subjects within the exclusion period of another clinical trial
* Failure to provide written informed consent

Primary outcomes:
measure: Functional outcome of the procedure (absolute value)
timeFrame: At the end of the procedure, once the operator judges the result to be satisfactory.
Secondary outcomes:
measure: Functional outcome of the procedure (dichotomized)
timeFrame: At the end of the procedure, once the operator judges the result to be satisfactory.
measure: Relative change in final FFR value
timeFrame: At the end of the angioplasty procedure
measure: Percentage of patients in whom OCT after stent implantation reveals a suboptimal result
timeFrame: Immediately after stent implantation
measure: Percentage of patients in whom a change in procedural strategy is decided based on OCT data
timeFrame: Immediately after stent implantation
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: Safety of OCT in angioplasty of the left main stem
timeFrame: At the end of the angioplasty procedure
measure: OCT data that predict final FFR value >=0.90
timeFrame: At the end of the angioplasty procedure
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besancon
state: Please Select
city: Lille
country: France
facility: CHRU Lille
state: Please Select
city: Caen
country: France
facility: Hôpital Privé Saint Martin
city: Chartres
country: France
facility: Centre Hospitalier de Chartres - Hôpital Louis Pasteur
city: Clermont-Ferrand
country: France
facility: CHRU Clermont Ferrand
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud
city: Nîmes
country: France
facility: CHU Nîmes - Hôpital Carémeau
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint-Laurent-du-Var
country: France
facility: Institut Arnault Tzanck
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
affiliation: Cardiology Department, CHU Besancon
name: Nicolas Meneveau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrancois Y, Descotes-Genon V, Silvain J, Braik N, Chopard R, Chatot M, Ecarnot F, Tauzin H, Van Belle E, Belle L, Schiele F. Optical Coherence Tomography to Optimize Results of Percutaneous Coronary Intervention in Patients with Non-ST-Elevation Acute Coronary Syndrome: Results of the Multicenter, Randomized DOCTORS Study (Does Optical Coherence Tomography Optimize Results of Stenting). Circulation. 2016 Sep 27;134(13):906-17. doi: 10.1161/CIRCULATIONAHA.116.024393. Epub 2016 Aug 29.