UnknownNot Applicable

Does OCT Optimise Results of Stenting on the Left Main Stem

France188 participantsStarted 2020-08-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 prote…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional outcome of the procedure (absolute value)

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

Trial details

NCT IDNCT04391413

SponsorCentre Hospitalier Universitaire de Besancon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-16

View on ClinicalTrials.gov More Myocardial Infarction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.