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

Primary Purpose

Myocardial Infarction, Myocardial Ischemia, Non ST Segment Elevation Myocardial Infarction

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of OCT to guide the angioplasty procedure
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring left main stem, angioplasty, optical coherence tomography, myocardial infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Besancon
  • CHRU Lille
  • Hôpital Privé Saint Martin
  • Centre Hospitalier de Chartres - Hôpital Louis Pasteur
  • CHRU Clermont Ferrand
  • Institut Cardiovasculaire Paris Sud
  • CHU Nîmes - Hôpital Carémeau
  • Institut Mutualiste Montsouris
  • CHU Poitiers
  • Clinique Saint Hilaire
  • Institut Arnault Tzanck
  • Hôpital Nord Franche-Comté

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

OCT group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Functional outcome of the procedure (dichotomized)
Percentage of patients with a final fractional flow reserve (FFR) value >=0.90
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
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
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
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)
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)
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)
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)
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)
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
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

Full Information

First Posted
April 2, 2020
Last Updated
November 9, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04391413
Brief Title
Does OCT Optimise Results of Stenting on the Left Main Stem
Acronym
DOCTORS-LM
Official Title
Does Optical Coherence Tomography Optimise Results of Stenting of the Left Main Stem
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
July 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Myocardial Ischemia, Non ST Segment Elevation Myocardial Infarction
Keywords
left main stem, angioplasty, optical coherence tomography, myocardial infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OCT group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of OCT to guide the angioplasty procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional outcome of the procedure (absolute value)
Description
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.
Secondary Outcome Measure Information:
Title
Functional outcome of the procedure (dichotomized)
Description
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.
Title
Relative change in final FFR value
Description
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
Title
Percentage of patients in whom OCT after stent implantation reveals a suboptimal result
Description
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
Title
Percentage of patients in whom a change in procedural strategy is decided based on OCT data
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
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
Title
Safety of OCT in angioplasty of the left main stem
Description
Safety of OCT in angioplasty of the left main stem, as assessed by procedural complications
Time Frame
At the end of the angioplasty procedure
Title
OCT data that predict final FFR value >=0.90
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Meneveau, MD, PhD
Organizational Affiliation
Cardiology Department, CHU Besancon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besançon
State/Province
Please Select
ZIP/Postal Code
25000
Country
France
Facility Name
CHRU Lille
City
Lille
State/Province
Please Select
Country
France
Facility Name
Hôpital Privé Saint Martin
City
Caen
Country
France
Facility Name
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
City
Chartres
Country
France
Facility Name
CHRU Clermont Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
Institut Cardiovasculaire Paris Sud
City
Massy
Country
France
Facility Name
CHU Nîmes - Hôpital Carémeau
City
Nîmes
Country
France
Facility Name
Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Facility Name
Clinique Saint Hilaire
City
Rouen
Country
France
Facility Name
Institut Arnault Tzanck
City
Saint-Laurent-du-Var
Country
France
Facility Name
Hôpital Nord Franche-Comté
City
Trévenans
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27573032
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.
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Does OCT Optimise Results of Stenting on the Left Main Stem

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