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

Last updated: March 11, 2025
Sponsor: TCROSS Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Angina

Thrombosis

Treatment

N/A

Clinical Study ID

NCT06436092
JDEPTH-LM Registry
jRCT1030240071
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 bycoronary angiography

  7. De novo target lesion in LMT-LAD amenable for crossover stenting with provisionalside-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 lessthan 70% confirmed by coronary angiography

Exclusion

Exclusion Criteria:

  1. Inability to provide written informed consent

  2. Patient with a history of ST-elevation myocardial infarction within the previous 1week

  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 lessthan one year

  6. Patient considered suitable for stent placement in the ostial LCx from a medicalperspective

  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

Study Design

Total Participants: 280
Study Start date:
May 27, 2024
Estimated Completion Date:
December 31, 2029

Study Description

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.

Connect with a study center

  • Ichinomiya Municipal Hospital

    Ichinomiya, Aichi
    Japan

    Active - Recruiting

  • Fujita Health University School of Medicine

    Toyoake, Aichi
    Japan

    Site Not Available

  • New Tokyo Hospital

    Matsudo, Chiba
    Japan

    Active - Recruiting

  • Tokyo Bay Urayasu Ichikawa Medical Center

    Urayasu, Chiba
    Japan

    Active - Recruiting

  • Ehime Prefectural Central Hospital

    Matsuyama, Ehime
    Japan

    Active - Recruiting

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka
    Japan

    Site Not Available

  • Gunma University Hospital

    Maebashi, Gunma
    Japan

    Site Not Available

  • Hakodate Municipal Hospital

    Hakodate, Hokkaido
    Japan

    Active - Recruiting

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido
    Japan

    Active - Recruiting

  • Tsuchiura Kyodo General Hospital

    Tsuchiura, Ibaraki
    Japan

    Active - Recruiting

  • Tsukuba Medical Center Hospital

    Tsukuba, Ibaraki
    Japan

    Site Not Available

  • Kanazawa Cardiovascular Hospital

    Kanazawa, Ishikawa
    Japan

    Active - Recruiting

  • Memorial Heart Center Iwate Medical University

    Morioka, Iwate
    Japan

    Active - Recruiting

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa
    Japan

    Active - Recruiting

  • Kitasato University School of Medicine

    Sagamihara, Kanagawa
    Japan

    Active - Recruiting

  • Yokosuka Kyosai Hospital

    Yokosuka, Kanagawa
    Japan

    Active - Recruiting

  • Shinshu University Hospital

    Matsumoto, Nagano
    Japan

    Active - Recruiting

  • Kurashiki Central Hospital

    Kurashiki, Okayama
    Japan

    Site Not Available

  • Urasoe General Hospital

    Urasoe, Okinawa
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital

    Bunkyo, Tokyo
    Japan

    Site Not Available

  • Moriyama Memorial Hospital

    Edogawa, Tokyo
    Japan

    Active - Recruiting

  • Sakakibara Heart Institute

    Fuchu, Tokyo
    Japan

    Active - Recruiting

  • Jikei University Katsushika Medical Center

    Katsushika, Tokyo
    Japan

    Active - Recruiting

  • NTT Medical Center Tokyo

    Shinagawa, Tokyo
    Japan

    Active - Recruiting

  • Keio University Hospital

    Shinjuku, Tokyo
    Japan

    Site Not Available

  • Chiba University Hospital

    Chiba,
    Japan

    Active - Recruiting

  • Fukuoka Wajiro Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka,
    Japan

    Site Not Available

  • Gifu Heart Center

    Gifu,
    Japan

    Active - Recruiting

  • Chikamori Hospital

    Kochi,
    Japan

    Active - Recruiting

  • Kumamoto University Hospital

    Kumamoto,
    Japan

    Active - Recruiting

  • Japanese Red Cross Wakayama Medical Center

    Wakayama,
    Japan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.