Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 280
- Locations
- 32
- Primary Endpoint
- Procedure success rate
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Procedure success rate
Time Frame: During PCI procedure
indicating the proportion of cases meeting the following three conditions: * Device delivery success * Achievement of DCB expansion for 30 seconds or more * No bailout stenting performed in the LCx
Major adverse cardiovascular event (MACE) at 12 months
Time Frame: Within 12 months of PCI procedure
consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
Secondary Outcomes
- Total DCB Inflation time(During PCI procedure)
- Maximum changes in blood pressure and heart rate(During PCI procedure)
- Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT(During PCI procedure)
- Time to ST-change from DCB inflation(During PCI procedure)
- Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium(Within 12 months of PCI)