RecruitingNCT06436092
Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Sponsor
TCROSS Co., Ltd.
Enrollment
280 participants
Start Date
May 27, 2024
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria9
- 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
- Lesion indicated in No. 8 with a length of less than 10 mm or a stenosis of less than 70% confirmed by coronary angiography
Exclusion Criteria8
- 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
- Patient considered suitable for stent placement in the ostial LCx from a medical perspective
- Patient considered unsuitable for anti-thrombotic therapy after PCI
- Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
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Locations(32)
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NCT06436092
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