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
- Diseases
- Coronary artery disease
- 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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
| Hôpital Privé Saint Martin Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Centre Hospitalier de Chartres - Hôpital Louis Pasteur Coordinator of this site? Confirm its status | Chartres | France | Unknown status |
| CHRU Clermont Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Institut Cardiovasculaire Paris Sud Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| CHU Nimes - Hôpital Caremeau Coordinator of this site? Confirm its status | Nîmes | France | Unknown status |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Institut Arnault Tzanck Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Unknown status |
| Hôpital Nord Franche-Comté Coordinator of this site? Confirm its status | Trévenans | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.