Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Stable Angina, Non-ST-elevation Acute Coronary Syndrome, Unstable Angina. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.
Primary outcome measures
- Procedure success rate [Time frame: During PCI procedure]
- Major adverse cardiovascular event (MACE) at 12 months [Time frame: Within 12 months of PCI procedure]
Secondary outcome measures (5)
- Time to ST-change from DCB inflation [Time frame: During PCI procedure]
- Total DCB Inflation time [Time frame: During PCI procedure]
- Maximum changes in blood pressure and heart rate [Time frame: During PCI procedure]
- Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT [Time frame: During PCI procedure]
- Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium [Time frame: Within 12 months of PCI]
Eligibility criteria
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
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Japan · 32 centers
- Ichinomiya Municipal Hospital — Ichinomiya
- Fujita Health University School of Medicine — Toyoake
- Chiba University Hospital — Chiba
- New Tokyo Hospital — Matsudo
- Tokyo Bay Urayasu Ichikawa Medical Center — Urayasu
- Ehime Prefectural Central Hospital — Matsuyama
- Fukuoka Wajiro Hospital — Fukuoka
- National Hospital Organization Kyushu Medical Center — Fukuoka
- … and 24 more centers
Identifiers
NCT: NCT06436092 · JDEPTH-LM Registry · jRCT1030240071