Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)

Launched by TCROSS CO., LTD. · May 28, 2024

Keywords

ClinConnect Summary

The JDEPTH-LM Registry is a clinical trial looking at a specific treatment technique for patients with left main coronary artery disease, which is a serious condition affecting the heart's blood supply. This study aims to evaluate how effective and safe a method called the Double-effect kissing balloon technique (W-KBT) is when used during a procedure known as percutaneous coronary intervention (PCI). The trial is focused on patients who have stable angina or types of acute coronary syndrome, with a particular emphasis on those with blockages in the left main artery and surrounding areas.

To participate in this trial, individuals must be at least 18 years old and have been diagnosed with certain heart conditions like stable coronary artery disease or unstable angina. They also need to have specific types of blockages confirmed by imaging tests. Participants will receive the PCI treatment and will be monitored closely for their safety and the effectiveness of the procedure. It’s important to note that some individuals may not qualify for the study, such as those who recently had a heart attack or have other serious health issues. If you or a loved one is considering participating, you'll be fully informed about the process and what to expect throughout the trial.

Gender

ALL

Eligibility criteria

• 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