Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry)
NCT ID: NCT06436092
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
280 participants
OBSERVATIONAL
2024-05-27
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Kaneka Corporation
INDUSTRY
TCROSS Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Hisaaki Ishiguro
Role: primary
Takashi Muramatsu
Role: primary
Yuichi Saito
Role: primary
Koji Hozawa
Role: primary
Masahiko Noguchi
Role: primary
Hideki Okayama
Role: primary
Takeshi Serikawa
Role: primary
Yoshinobu Murasato
Role: primary
Takenori Domei
Role: primary
Yoshiaki Kawase
Role: primary
Takashi Nagasaka
Role: primary
Yusuke Tokuda
Role: primary
Yuki Katagiri
Role: primary
Tsunekazu Kakuta
Role: primary
Hidetaka Nishina
Role: primary
Hidenobu Terai
Role: primary
Kai Ninomiya
Role: primary
Koki Shishido
Role: primary
Yoshiyasu Minami
Role: primary
Tadashi Murai
Role: primary
Ryu-Ichirou Imai
Role: primary
Kenichi Tsujita
Role: primary
Yasushi Ueki
Role: primary
Hiroyuki Tanaka
Role: primary
Marohito Nakata
Role: primary
Hiroyuki Kiriyama
Role: primary
Arihiro Kiyosue
Role: primary
Kenichi Hagiya
Role: primary
Ryosuke Itakura
Role: primary
Takayuki Warisawa
Role: primary
Yohei Numasawa
Role: primary
Junichi Tazaki
Role: primary
Other Identifiers
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jRCT1030240071
Identifier Type: OTHER
Identifier Source: secondary_id
JDEPTH-LM Registry
Identifier Type: -
Identifier Source: org_study_id
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