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Recruiting Observational

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

NCT06436092 · tracked via the Priya Life Science Japan tracker
Sponsor
TCROSS Co., Ltd
Phase
Observational
Started
2024-05-27
Last updated
2025-03-13

Condition(s) studied

Stable AnginaNon-ST-elevation Acute Coronary SyndromeUnstable Angina

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Procedure success rate — 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 — Within 12 months of PCI procedure
    consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease

Trial sites (32)

FacilityCityRegionStatus
Ichinomiya Municipal Hospital Ichinomiya Aichi-ken Recruiting
Fujita Health University School of Medicine Toyoake Aichi-ken Not Yet Recruiting
Chiba University Hospital Chiba Chiba Recruiting
New Tokyo Hospital Matsudo Chiba Recruiting
Tokyo Bay Urayasu Ichikawa Medical Center Urayasu Chiba Recruiting
Ehime Prefectural Central Hospital Matsuyama Ehime Recruiting
Fukuoka Wajiro Hospital Fukuoka Fukuoka Recruiting
National Hospital Organization Kyushu Medical Center Fukuoka Fukuoka Not Yet Recruiting
Kokura Memorial Hospital Kitakyushu Fukuoka Not Yet Recruiting
Gifu Heart Center Gifu Gifu Recruiting
Gunma University Hospital Maebashi Gunma Not Yet Recruiting
Hakodate Municipal Hospital Hakodate Hokkaido Recruiting
Sapporo Higashi Tokushukai Hospital Sapporo Hokkaido Recruiting
Tsuchiura Kyodo General Hospital Tsuchiura Ibaraki Recruiting
Tsukuba Medical Center Hospital Tsukuba Ibaraki Not Yet Recruiting
Kanazawa Cardiovascular Hospital Kanazawa Ishikawa-ken Recruiting
Memorial Heart Center Iwate Medical University Morioka Iwate Recruiting
Shonan Kamakura General Hospital Kamakura Kanagawa Recruiting
Kitasato University School of Medicine Sagamihara Kanagawa Recruiting
Yokosuka Kyosai Hospital Yokosuka Kanagawa Recruiting
Chikamori Hospital Kochi Kochi Recruiting
Kumamoto University Hospital Kumamoto Kumamoto Recruiting
Shinshu University Hospital Matsumoto Nagano Recruiting
Kurashiki Central Hospital Kurashiki Okayama-ken Not Yet Recruiting
Urasoe General Hospital Urasoe Okinawa Recruiting
The University of Tokyo Hospital Bunkyo Tokyo Not Yet Recruiting
Moriyama Memorial Hospital Edogawa City Tokyo Recruiting
Sakakibara Heart Institute Fuchū Tokyo Recruiting
Jikei University Katsushika Medical Center Katsushika-ku Tokyo Recruiting
NTT Medical Center Tokyo Shinagawa Tokyo Recruiting
Keio University Hospital Shinjuku Tokyo Not Yet Recruiting
Japanese Red Cross Wakayama Medical Center Wakayama Wakayama Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06436092 on ClinicalTrials.gov ↗ ← All trials in Japan