Registry for coronary intervention using drug-eluting balloons for left main disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The JDEPTH-LM Registry is a prospective, observational, multi-center initiative aimed at assessing the efficacy and safety of the Double-effect kissing balloon technique (W-KBT) in patients with left main coronary artery disease. Participants will undergo percutaneous coronary intervention (PCI) using a combination of perfusion balloons and drug-coated balloons, with treatment decisions made by a local Heart Team. The study will continuously register cases and evaluate outcomes based on standard care protocols, ensuring informed consent is obtained from all participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Ichinomiya Municipal Hospital
  Ichinomiya, Aichi-ken, Japan Recruiting
• Chiba University Hospital
  Chiba, Chiba, Japan Recruiting
• New Tokyo Hospital
  Matsudo, Chiba, Japan Recruiting
• Tokyo Bay Urayasu Ichikawa Medical Center
  Urayasu, Chiba, Japan Recruiting
• Ehime Prefectural Central Hospital
  Matsuyama, Ehime, Japan Recruiting
• Fukuoka Wajiro Hospital
  Fukuoka, Fukuoka, Japan Recruiting

Study contacts

• Study coordinator: Takayuki Warisawa, MD, PhD
• Email: warisawa-tky@umin.ac.jp
• Phone: 81-3-3448-6111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.