Does OCT Optimise Results of Stenting on the Left Main Stem

NCT04391413 | Unknown

• 1 other identifier: 2020-A00532-37
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 12

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.

Conditions

Myocardial Infarction; Myocardial Ischemia; Non ST Segment Elevation Myocardial Infarction

Keywords

left main stem; angioplasty; optical coherence tomography; myocardial infarction

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (11)

• Functional outcome of the procedure (dichotomized)

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

• Relative change in final FFR value

  At the end of the angioplasty procedure

• Percentage of patients in whom OCT after stent implantation reveals a suboptimal result

  Immediately after stent implantation

• Percentage of patients in whom a change in procedural strategy is decided based on OCT data

  Immediately after stent implantation

• Safety of OCT in angioplasty of the left main stem

  At the end of the angioplasty procedure

Study Arms (2)

OCT group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Use of OCT to guide the angioplasty procedure DEVICE

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.

OCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (12)

CHU Besancon

Besançon, Please Select, 25000, France

Location

CHRU Lille

Lille, Please Select, France

Location

Hôpital Privé Saint Martin

Caen, France

Location

Centre Hospitalier de Chartres - Hôpital Louis Pasteur

Chartres, France

Location

CHRU Clermont Ferrand

Clermont-Ferrand, France

Location

Institut Cardiovasculaire Paris Sud

Massy, France

Location

CHU Nîmes - Hôpital Carémeau

Nîmes, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

CHU Poitiers

Poitiers, France

Location

Clinique Saint Hilaire

Rouen, France

Location

Institut Arnault Tzanck

Saint-Laurent-du-Var, France

Location

Hôpital Nord Franche-Comté

Trévenans, France

Location

Related Publications (1)

• 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.

  PMID: 27573032 RESULT

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Nicolas Meneveau, MD, PhD

  Cardiology Department, CHU Besancon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: May 18, 2020
• Study Start: August 7, 2020
• Primary Completion: June 16, 2022
• Study Completion: July 16, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)