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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
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.
CHU Besancon
Besançon, Please Select, France
CHRU Lille
Lille, Please Select, France
Hôpital Privé Saint Martin
Caen, France
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
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)
Time frame: At the end of the procedure, once the operator judges the result to be satisfactory.
Functional outcome of the procedure (dichotomized)
Percentage of patients with a final fractional flow reserve (FFR) value \>=0.90
Time frame: At the end of the procedure, once the operator judges the result to be satisfactory.
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
Time frame: At the end of the angioplasty procedure
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
Time frame: Immediately after stent implantation
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
Time frame: Immediately after stent implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Chartres, France
CHRU Clermont Ferrand
Clermont-Ferrand, 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
...and 2 more locations
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)
Time frame: At the end of the angioplasty procedure
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)
Time frame: At the end of the angioplasty procedure
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)
Time frame: At the end of the angioplasty procedure
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)
Time frame: At the end of the angioplasty procedure
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)
Time frame: At the end of the angioplasty procedure
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
Time frame: At the end of the angioplasty procedure
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
Time frame: At the end of the angioplasty procedure