Does OCT Optimise Results of Stenting on the Left Main Stem (NCT04391413) | Clinical Trial Compass
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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 range18 Years
SexALL
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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…
What they're measuring
1
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