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

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ClinicalTrials.gov Identifier: NCT04391413
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 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
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

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.



Primary Outcome Measures :
  1. Functional outcome of the produre [ Time Frame: 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 :
  1. Percentage of patients in whom OCT after stent implantation reveals a suboptimal result [ Time Frame: 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

  2. Percentage of patients in whom a change in procedural strategy is decided based on OCT data [ Time Frame: 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

  3. Safety of OCT in angioplasty of the left main stem [ Time Frame: At the end of the angioplasty procedure ]
    Safety of OCT in angioplasty of the left main stem, as assessed by duration of procedure (minutes)

  4. Safety of OCT in angioplasty of the left main stem [ Time Frame: At the end of the angioplasty procedure ]
    Safety of OCT in angioplasty of the left main stem, as assessed by - fluoroscopy time (minutes)

  5. Safety of OCT in angioplasty of the left main stem [ Time Frame: At the end of the angioplasty procedure ]
    Safety of OCT in angioplasty of the left main stem, as assessed by Radiation dose received (MSv)

  6. Safety of OCT in angioplasty of the left main stem [ Time Frame: 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)

  7. Safety of OCT in angioplasty of the left main stem [ Time Frame: 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)

  8. Safety of OCT in angioplasty of the left main stem [ Time Frame: At the end of the angioplasty procedure ]
    Safety of OCT in angioplasty of the left main stem, as assessed by procedural complications

  9. OCT data that predict final FFR value >=0.90 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391413


Contacts
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Contact: Nicolas F Meneveau, MD, PhD 33381668539 nicolas.meneveau@univ-fcomte.fr
Contact: Fiona Ecarnot, PhD 33381668539 fiona.ecarnot@univ-fcomte.fr

Locations
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France
CHU Besancon
Besançon, Please Select, France, 25000
Contact: Fiona Ecarnot, PhD    33381668539    fiona.ecarnot@univ-fcomte.fr   
Sub-Investigator: Francois Schiele, MD, PhD         
Sub-Investigator: Romain Chopard, MD, PhD         
Sub-Investigator: Marion Chatot, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Nicolas Meneveau, MD, PhD Cardiology Department, CHU Besancon
Publications of Results:
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT04391413    
Other Study ID Numbers: 2020-A00532-37
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
left main stem
angioplasty
optical coherence tomography
myocardial infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Vascular Diseases