Does OCT Optimise Results of Stenting on the Left Main Stem

Myocardial Infarction Clinical Trial

— DOCTORS-LM  

Official title:

Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04391413
• Other study ID #: 2020-A00532-37
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: July 16, 2023

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 188
• Est. completion date: July 16, 2023
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Ischemia
• Myocardial Infarction
• Myocardial Ischemia
• Non ST Segment Elevation Myocardial Infarction

Intervention

Device:
• Use of OCT to guide the angioplasty procedure
OCT will be performed and OCT data used to choose and/or modify procedural strategy. The OCT system used will be the Ilumien Optis system, and Dragonfly Optis probe.

Locations

Country	Name	City	State
France	CHU Besancon	Besançon	Please Select
France	Hôpital Privé Saint Martin	Caen
France	Centre Hospitalier de Chartres - Hôpital Louis Pasteur	Chartres
France	CHRU Clermont Ferrand	Clermont-Ferrand
France	CHRU Lille	Lille	Please Select
France	Institut Cardiovasculaire Paris Sud	Massy
France	CHU Nîmes - Hôpital Carémeau	Nîmes
France	Institut Mutualiste Montsouris	Paris
France	CHU Poitiers	Poitiers
France	Clinique Saint Hilaire	Rouen
France	Institut Arnault Tzanck	Saint-Laurent-du-Var
France	Hôpital Nord Franche-Comté	Trévenans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

References & Publications (1)

Meneveau N, Souteyrand G, Motreff P, Caussin C, Amabile N, Ohlmann P, Morel O, Lefrançois 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome of the procedure (absolute value)	Functional outcome as assessed by the Fractional flow reserve (FFR) at the end of the procedure (average of at least 3 consecutive measures)	At the end of the procedure, once the operator judges the result to be satisfactory.
Secondary	Functional outcome of the procedure (dichotomized)	Percentage of patients with a final fractional flow reserve (FFR) value >=0.90	At the end of the procedure, once the operator judges the result to be satisfactory.
Secondary	Relative change in final FFR value	Relative change in final FFR value as compared to initial FFR value at the start of the procedure in each patient	At the end of the angioplasty procedure
Secondary	Percentage of patients in whom OCT after stent implantation reveals a suboptimal result	Percentage of patients in whom OCT after stenting reveals a sub-optimal result, defined as the presence of any one or more of the following criteria: Stent under expansion; Stent malapposition; Lesion incompletely covered by the stent; Residual stenosis upstream or downstream of the stent; Edge dissection; Thrombus; Tissue protrusion through the stent struts	Immediately after stent implantation
Secondary	Percentage of patients in whom a change in procedural strategy is decided based on OCT data	Percentage of patients in whom a change in procedural strategy is decided based on OCT data, with use of any one or more of the following: GPIIb/IIIa inhibitors; Thrombo aspiration; Rotational atherectomy; Additional stent implantation; Additional balloon inflations; Re-opening of strent struts in secondary branch	Immediately after stent implantation
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by duration of procedure (minutes)	At the end of the angioplasty procedure
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by - fluoroscopy time (minutes)	At the end of the angioplasty procedure
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by Radiation dose received (MSv)	At the end of the angioplasty procedure
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by Quantity of contrast medium used (mL)	At the end of the angioplasty procedure
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by change in creatinine clearance over the first 24 hours (Creatinine clearance in ml/min)	At the end of the angioplasty procedure
Secondary	Safety of OCT in angioplasty of the left main stem	Safety of OCT in angioplasty of the left main stem, as assessed by procedural complications	At the end of the angioplasty procedure
Secondary	OCT data that predict final FFR value >=0.90	Thresholds for minimal lumen diameter and minimal stent area on OCT that best predict a final FFR value >=0.90	At the end of the angioplasty procedure