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Myocardial InfarctionDOCTORS-LMNCT04391413

Does OCT Optimise Results of Stenting on the Left Main Stem

A study testing Use of OCT to guide the angioplasty procedure in people with Myocardial Infarction and Myocardial Ischemia, run by Centre Hospitalier Universitaire de Besancon at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Use of OCT to guide the angioplasty procedure
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
12 sitesFrance
Study dates
7 Aug 2020to 31 May 2024
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%
Show all 17Show fewer
  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • CHU Besancon

    Besançon, Please Select, 25000

  • Hôpital Privé Saint Martin

    Caen

  • Centre Hospitalier de Chartres - Hôpital Louis Pasteur

    Chartres

  • CHRU Clermont Ferrand

    Clermont-Ferrand

  • CHRU Lille

    Lille, Please Select

  • Institut Cardiovasculaire Paris Sud

    Massy

  • CHU Nîmes - Hôpital Carémeau

    Nîmes

  • Institut Mutualiste Montsouris

    Paris, 75014

  • CHU Poitiers

    Poitiers

  • Clinique Saint Hilaire

    Rouen

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var

  • Hôpital Nord Franche-Comté

    Trévenans

Other trials in France

About this study

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

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.

Read the 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.

Being tested
Use of OCT to guide the angioplasty procedure
Keywords
left main stem, angioplasty, optical coherence tomography, myocardial infarction
Medical subject headings
Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of OCT to guide the angioplasty procedureDevice

    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.

Study groups in NCT04391413
Study groupRoleWhat they receive
OCT groupExperimentalOCT 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.
Receives: Device: Use of OCT to guide the angioplasty procedure
Control groupNo interventionAngioplasty 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At the end of the procedure, once the operator judges the result to be satisfactory.

Secondary outcomes (11)

  1. Functional outcome of the procedure (dichotomized)

    Percentage of patients with a final fractional flow reserve (FFR) value >=0.90

    Measured: At the end of the procedure, once the operator judges the result to be satisfactory.

  2. 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

    Measured: At the end of the angioplasty procedure

  3. 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

    Measured: Immediately after stent implantation

  4. 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

    Measured: Immediately after stent implantation

  5. 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)

    Measured: At the end of the angioplasty procedure

  6. 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)

    Measured: At the end of the angioplasty procedure

  7. 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)

    Measured: At the end of the angioplasty procedure

  8. 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)

    Measured: At the end of the angioplasty procedure

  9. 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)

    Measured: At the end of the angioplasty procedure

  10. 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

    Measured: At the end of the angioplasty procedure

  11. 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

    Measured: At the end of the angioplasty procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start7 Aug 2020
  3. Primary completion16 Jun 2022
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04391413
Sponsor's protocol ID
2020-A00532-37
Acronym
DOCTORS-LM
Status last verified
Oct 2026
First submitted
2 Apr 2020
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27573032

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