Status:
UNKNOWN
Does OCT Optimise Results of Stenting on the Left Main Stem
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Myocardial Infarction
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Angiographic evaluation of lesions of the left main stem presents particular challenges and high procedural complexity. The clinical sequelae of a suboptimal result in this context may be severe, and ...
Eligibility Criteria
Inclusion
- 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
- 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
- Subjects within the exclusion period of another clinical trial
- Failure to provide written informed consent
Key Trial Info
Start Date :
August 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2023
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT04391413
Start Date
August 7 2020
End Date
July 16 2023
Last Update
November 10 2022
Active Locations (12)
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1
CHU Besancon
Besançon, Please Select, France, 25000
2
CHRU Lille
Lille, Please Select, France
3
Hôpital Privé Saint Martin
Caen, France
4
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
Chartres, France