DOCTORS-LM: Does OCT Optimise Results of Stenting on the Left Main Stem

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT04391413

Collaborator

(none)

188

Enrollment

Locations

Arms

Anticipated Duration (Months)

15.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Myocardial Ischemia Non ST Segment Elevation Myocardial Infarction	Device: Use of OCT to guide the angioplasty procedure	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 7, 2020

Anticipated Primary Completion Date :

Aug 7, 2022

Anticipated Study Completion Date :

Aug 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OCT group OCT will be performed after initial coronary angiography and at the end of the procedure. Several OCT runs can be performed. The operator may change procedural strategy, and use additional interventions. The operator must evaluate the following parameters, based on OCT data: Before angioplasty: reference diameter and reference area of distal main vessel; lesion length; presence and extent of thrombus or calcification. Stent implantation: Stent should be sized according to distal reference diameter, and should allow for expansion to the reference diameter of the proximal main vessel. After stent implantation: minimal and reference lumen diameter, minimal and reference lumen area, minimal stent area, presence of thrombus, presence of edge dissection, tissue protrusion, optimal lesion coverage, malapposition, suboptimal stent deployment.	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.
No Intervention: Control group Angioplasty will be guided by traditional fluoroscopy alone, performed before and after stent implantation. The recommendation for angioplasty of left main stenosis is to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. Predilatation of the side branch (SB) may be considered, but is recommended in the following circumstances: extensive ostial SB involvement, heavy calcification, etc. even with a provisional SB stenting approach.

Arm

Intervention/Treatment

Experimental: OCT group

OCT will be performed after initial coronary angiography and at the end of the procedure. Several OCT runs can be performed. The operator may change procedural strategy, and use additional interventions. The operator must evaluate the following parameters, based on OCT data: Before angioplasty: reference diameter and reference area of distal main vessel; lesion length; presence and extent of thrombus or calcification. Stent implantation: Stent should be sized according to distal reference diameter, and should allow for expansion to the reference diameter of the proximal main vessel. After stent implantation: minimal and reference lumen diameter, minimal and reference lumen area, minimal stent area, presence of thrombus, presence of edge dissection, tissue protrusion, optimal lesion coverage, malapposition, suboptimal stent deployment.

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.

No Intervention: Control group

Angioplasty will be guided by traditional fluoroscopy alone, performed before and after stent implantation. The recommendation for angioplasty of left main stenosis is to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. Predilatation of the side branch (SB) may be considered, but is recommended in the following circumstances: extensive ostial SB involvement, heavy calcification, etc. even with a provisional SB stenting approach.

Outcome Measures

Primary Outcome Measures

Functional outcome of the procedure (absolute value) [At the end of the procedure, once the operator judges the result to be satisfactory.]
Functional outcome as assessed by the Fractional flow reserve (FFR) at the end of the procedure (average of at least 3 consecutive measures)

Secondary Outcome Measures

Functional outcome of the procedure (dichotomized) [At the end of the procedure, once the operator judges the result to be satisfactory.]
Percentage of patients with a final fractional flow reserve (FFR) value >=0.90
Relative change in final FFR value [At the end of the angioplasty procedure]
Relative change in final FFR value as compared to initial FFR value at the start of the procedure in each patient
Percentage of patients in whom OCT after stent implantation reveals a suboptimal result [Immediately after stent implantation]
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
Percentage of patients in whom a change in procedural strategy is decided based on OCT data [Immediately after stent implantation]
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
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
Safety of OCT in angioplasty of the left main stem, as assessed by duration of procedure (minutes)
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
Safety of OCT in angioplasty of the left main stem, as assessed by - fluoroscopy time (minutes)
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
Safety of OCT in angioplasty of the left main stem, as assessed by Radiation dose received (MSv)
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
Safety of OCT in angioplasty of the left main stem, as assessed by Quantity of contrast medium used (mL)
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
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)
Safety of OCT in angioplasty of the left main stem [At the end of the angioplasty procedure]
Safety of OCT in angioplasty of the left main stem, as assessed by procedural complications
OCT data that predict final FFR value >=0.90 [At the end of the angioplasty procedure]
Thresholds for minimal lumen diameter and minimal stent area on OCT that best predict a final FFR value >=0.90

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Besancon	Besançon	Please Select	France	25000
2	CHRU Lille	Lille	Please Select	France
3	Hôpital Privé Saint Martin	Caen		France
4	Centre Hospitalier de Chartres - Hôpital Louis Pasteur	Chartres		France
5	CHRU Clermont Ferrand	Clermont-Ferrand		France
6	Institut Cardiovasculaire Paris Sud	Massy		France
7	CHU Nîmes - Hôpital Carémeau	Nîmes		France
8	Institut Mutualiste Montsouris	Paris		France	75014
9	CHU Poitiers	Poitiers		France
10	Clinique Saint Hilaire	Rouen		France
11	Institut Arnault Tzanck	Saint-Laurent-du-Var		France
12	Hôpital Nord Franche-Comté	Trévenans		France