JDEPTH-LM Registry

JRCT ID: jRCT1030240071

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Stable angina, non-ST-elevation acute coronary syndrome, Unstable angina
• Date of first enrollment: 27/05/2024
• Target sample size: 280
• Study type: Observational

Outcome(s)

Primary Outcome

1. Procedure success rate:
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

2. MACE at 12 months:
consisting of all-cause mortality, nonfatal MI, and ischemia-driven unplanned revascularization for left main disease

Secondary Outcome

- Time to ST-change from DCB inflation
- Total DCB Inflation time
- Maximum changes in blood pressure and heart rate
- Use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
- Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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) 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

Exclude 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

Related Information

• Primary Sponsor: Warisawa Takayuki
• Source(s) of Monetary Support: KANEKA CORPORATION