Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JD… (NCT06436092) | Clinical Trial Compass
RecruitingNot Applicable
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Japan280 participantsStarted 2024-05-27
Plain-language summary
JDEPTH-LM Registry is a prospective, observational, multi-center study designed for the efficacy and safety of Double-effect kissing balloon technique (W-KBT) in left main (LM) bifurcation percutaneous coronary intervention (PCI) using Perfusion balloon (PB) and Drug coated balloon (DCB) in patients with left main coronary artery disease (LMD) with left circumflex artery (LCx) ostium stenosis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina
✓. Left main disease confirmed by coronary angiography or coronary CT angiography
✓. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team
✓. Patient with consent prior to undergoing PCI
✓. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography
✓. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator
✓. De novo ostial LCx lesions
Exclusion criteria
✕. Inability to provide written informed consent
✕. Patient with a history of ST-elevation myocardial infarction within the previous 1 week
✕. Patient in a state of cardiogenic shock
✕. Patient with a history of coronary artery bypass grafting
✕. Patient with malignant tumors or other conditions with a life expectancy of less than one year
What they're measuring
1
Procedure success rate
Timeframe: During PCI procedure
2
Major adverse cardiovascular event (MACE) at 12 months