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

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-27

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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JDEPTH-LM Registry is a prospective observational multi-center study. The investigators will enroll and treat patients in the registry who meet the selection criteria under usual care and for whom PCI with W-KBT following on crossover stenting for LMT-LAD direction, proximal optimization technique (POT), and conventional kissing balloon technique (C-KBT) is the optimal treatment. The operators shall obtain oral or written consent from patients who meet the criteria before performing PCI, indicating the intention to perform PCI with W-KBT, and shall keep records. The investigators will continuously register cases attempting PCI with W-KBT according to the protocol and evaluate its efficacy and safety using data from this multi-center registry.

Conditions

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Stable Angina Non-ST-elevation Acute Coronary Syndrome Unstable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaneka Corporation

INDUSTRY

Sponsor Role collaborator

TCROSS Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ichinomiya Municipal Hospital

Ichinomiya, Aichi-ken, Japan

Site Status RECRUITING

Fujita Health University School of Medicine

Toyoake, Aichi-ken, Japan

Site Status NOT_YET_RECRUITING

Chiba University Hospital

Chiba, Chiba, Japan

Site Status RECRUITING

New Tokyo Hospital

Matsudo, Chiba, Japan

Site Status RECRUITING

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Site Status RECRUITING

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Site Status RECRUITING

Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Site Status NOT_YET_RECRUITING

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Site Status NOT_YET_RECRUITING

Gifu Heart Center

Gifu, Gifu, Japan

Site Status RECRUITING

Gunma University Hospital

Maebashi, Gunma, Japan

Site Status NOT_YET_RECRUITING

Hakodate Municipal Hospital

Hakodate, Hokkaido, Japan

Site Status RECRUITING

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Site Status RECRUITING

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, Japan

Site Status RECRUITING

Tsukuba Medical Center Hospital

Tsukuba, Ibaraki, Japan

Site Status NOT_YET_RECRUITING

Kanazawa Cardiovascular Hospital

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Memorial Heart Center Iwate Medical University

Morioka, Iwate, Japan

Site Status RECRUITING

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Site Status RECRUITING

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

Site Status RECRUITING

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

Site Status RECRUITING

Chikamori Hospital

Kochi, Kochi, Japan

Site Status RECRUITING

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Site Status RECRUITING

Shinshu University Hospital

Matsumoto, Nagano, Japan

Site Status RECRUITING

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Site Status NOT_YET_RECRUITING

Urasoe General Hospital

Urasoe, Okinawa, Japan

Site Status RECRUITING

The University of Tokyo Hospital

Bunkyo, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Moriyama Memorial Hospital

Edogawa City, Tokyo, Japan

Site Status RECRUITING

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Site Status RECRUITING

Jikei University Katsushika Medical Center

Katsushika-ku, Tokyo, Japan

Site Status RECRUITING

NTT Medical Center Tokyo

Shinagawa, Tokyo, Japan

Site Status RECRUITING

Keio University Hospital

Shinjuku, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Japanese Red Cross Wakayama Medical Center

Wakayama, Wakayama, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takayuki Warisawa, MD, PhD

Role: CONTACT

81-3-3448-6111

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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