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Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
RECRUITINGSponsored by TCROSS Co., Ltd.
Actively Recruiting
SponsorTCROSS Co., Ltd.
Started2024-05-27
Est. completion2027-05-31
Eligibility
Age18 Years+
View on ClinicalTrials.gov →
NCT06436092
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
Age: 18 Years+
Inclusion Criteria: 1. Age ≥ 18 years 2. Patient with stable coronary artery disease, non-ST-elevation myocardial infarction, or unstable angina 3. Left main disease confirmed by coronary angiography or coronary CT angiography 4. Clinical and anatomical eligibility for PCI as agreed by the local Heart Team 5. Patient with consent prior to undergoing PCI 6. Left main Medina classification (1,1,1), (1,0,1), (0,1,1), (0,0,1) confirmed by coronary angiography 7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisional side-branch approach as determined by PCI operator 8. De novo ostial LCx lesions 9. 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 Criteria: 1. Inability to provide written informed consent 2. Patient with a history of ST-elevation myocardial infarction within the previous 1 week 3. Patient in a state of cardiogenic shock 4. Patient with a history of coronary artery bypass grafting 5. Patient with malignant tumors or other conditions with a life expectancy of less than one year 6. Patient considered suitable for stent placement in the ostial LCx from a medical perspective 7. Patient considered unsuitable for anti-thrombotic therapy after PCI 8. Other patient whom the investigator deems unsuitable for the safe conduct of LM-PCI, including W-KBT
Conditions4
Heart DiseaseNon-ST-elevation Acute Coronary SyndromeStable AnginaUnstable Angina
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Actively Recruiting
SponsorTCROSS Co., Ltd.
Started2024-05-27
Est. completion2027-05-31
Eligibility
Age18 Years+
View on ClinicalTrials.gov →
NCT06436092