Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
2 other identifiers
observational
280
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
Longer than P75 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2024
CompletedStudy Start
First participant enrolled
May 27, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
March 13, 2025
March 1, 2025
3 years
May 10, 2024
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
During PCI procedure
Major adverse cardiovascular event (MACE) at 12 months
consisting of all-cause mortality, nonfatal myocardial infarction (MI), and ischemia-driven unplanned revascularization for left main disease
Within 12 months of PCI procedure
Secondary Outcomes (5)
Time to ST-change from DCB inflation
During PCI procedure
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
Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
Within 12 months of PCI
Other Outcomes (10)
Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
During PCI procedure
ST-change recovery time
During PCI procedure
Incidence of periprocedural MI defined by Fourth Universal Definition of Myocardial Infarction (4th UDMI), Academic Research Consortium (ARC)-2 and Society for Cardiovascular Angiography and Interventions (SCAI) definitions
Within 12 months of PCI
- +7 more other outcomes
Study Arms (1)
JDEPTH-LM Registry Participants
Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
Eligibility Criteria
Subjects ≥ 18 years of age with de novo LMD with LCx ostium stenosis presenting with stable angina, non-ST-elevation myocardial infarction, or unstable angina that are suitable for percutaneous coronary intervention including W-KBT processes. Approximately 280 subjects at 17 sites in Japan will be enrolled. Subjects will be followed through discharge and 12 months in routine clinical practice.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TCROSS Co., Ltd.lead
- Kaneka Corporationcollaborator
Study Sites (32)
Ichinomiya Municipal Hospital
Ichinomiya, Aichi-ken, Japan
Fujita Health University School of Medicine
Toyoake, Aichi-ken, Japan
Chiba University Hospital
Chiba, Chiba, Japan
New Tokyo Hospital
Matsudo, Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan
Fukuoka Wajiro Hospital
Fukuoka, Fukuoka, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Gifu Heart Center
Gifu, Gifu, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Hakodate Municipal Hospital
Hakodate, Hokkaido, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, Japan
Tsuchiura Kyodo General Hospital
Tsuchiura, Ibaraki, Japan
Tsukuba Medical Center Hospital
Tsukuba, Ibaraki, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Ishikawa-ken, Japan
Memorial Heart Center Iwate Medical University
Morioka, Iwate, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, Japan
Kitasato University School of Medicine
Sagamihara, Kanagawa, Japan
Yokosuka Kyosai Hospital
Yokosuka, Kanagawa, Japan
Chikamori Hospital
Kochi, Kochi, Japan
Kumamoto University Hospital
Kumamoto, Kumamoto, Japan
Shinshu University Hospital
Matsumoto, Nagano, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
Urasoe General Hospital
Urasoe, Okinawa, Japan
The University of Tokyo Hospital
Bunkyo, Tokyo, Japan
Moriyama Memorial Hospital
Edogawa City, Tokyo, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, Japan
Jikei University Katsushika Medical Center
Katsushika-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa, Tokyo, Japan
Keio University Hospital
Shinjuku, Tokyo, Japan
Japanese Red Cross Wakayama Medical Center
Wakayama, Wakayama, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2024
First Posted
May 30, 2024
Study Start
May 27, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
March 13, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share