Fact CheckerSign in

NCT04391413Completed

Does OCT Optimise Results of Stenting on the Left Main Stem

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
197 (actual)
First submitted
2 Apr 2020
Start date
7 Aug 2020
Primary completion date
16 Jun 2022
Lead sponsor
Centre Hospitalier Universitaire de Besancon
NCT number
NCT04391413

What you commit to

  • Study type: Interventional
  • Participants enrolled: 197
  • From 7 Aug 2020 to the primary completion date, 16 Jun 2022
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • ST segment elevation myocardial infarction
  • Unstable ventricular arrhythmia
  • Hypersensitivity or contraindication to any of the antithrombotic therapies used during or after the procedure
  • Failure to provide written informed consent

Lab values

  • Creatinine clearance ≤ 30 ml/min/1.73m²
  • Left ventricular ejection fraction \<30%

Other

  • Patients with:
  • Ostial lesion of the left main stem
  • Technically impossible to perform OCT
  • Hypotension or cardiogenic shock
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Besançon
Coordinator of this site? Confirm its status
BesançonFranceUnknown status
Hôpital Privé Saint Martin
Coordinator of this site? Confirm its status
CaenFranceUnknown status
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
Coordinator of this site? Confirm its status
ChartresFranceUnknown status
CHRU Clermont Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
CHRU Lille
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Institut Cardiovasculaire Paris Sud
Coordinator of this site? Confirm its status
MassyFranceUnknown status
CHU Nimes - Hôpital Caremeau
Coordinator of this site? Confirm its status
NîmesFranceUnknown status
Institut Mutualiste Montsouris
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceUnknown status
Clinique Saint-Hilaire
Coordinator of this site? Confirm its status
RouenFranceUnknown status
Institut Arnault Tzanck
Coordinator of this site? Confirm its status
Saint-Laurent-du-VarFranceUnknown status
Hôpital Nord Franche-Comté
Coordinator of this site? Confirm its status
TrévenansFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.