Actively Recruiting

Age: 18Years +
All Genders
NCT06436092

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

Led by TCROSS Co., Ltd. · Updated on 2025-03-13

280

Participants Needed

32

Research Sites

292 weeks

Total Duration

On this page

Sponsors

T

TCROSS Co., Ltd.

Lead Sponsor

K

Kaneka Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 32 locations

1

Ichinomiya Municipal Hospital

Ichinomiya, Aichi-ken, Japan

Actively Recruiting

2

Fujita Health University School of Medicine

Toyoake, Aichi-ken, Japan

Not Yet Recruiting

3

Chiba University Hospital

Chiba, Chiba, Japan

Actively Recruiting

4

New Tokyo Hospital

Matsudo, Chiba, Japan

Actively Recruiting

5

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu, Chiba, Japan

Actively Recruiting

6

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Actively Recruiting

7

Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, Japan

Actively Recruiting

8

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, Japan

Not Yet Recruiting

9

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Not Yet Recruiting

10

Gifu Heart Center

Gifu, Gifu, Japan

Actively Recruiting

11

Gunma University Hospital

Maebashi, Gunma, Japan

Not Yet Recruiting

12

Hakodate Municipal Hospital

Hakodate, Hokkaido, Japan

Actively Recruiting

13

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Actively Recruiting

14

Tsuchiura Kyodo General Hospital

Tsuchiura, Ibaraki, Japan

Actively Recruiting

15

Tsukuba Medical Center Hospital

Tsukuba, Ibaraki, Japan

Not Yet Recruiting

16

Kanazawa Cardiovascular Hospital

Kanazawa, Ishikawa-ken, Japan

Actively Recruiting

17

Memorial Heart Center Iwate Medical University

Morioka, Iwate, Japan

Actively Recruiting

18

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Actively Recruiting

19

Kitasato University School of Medicine

Sagamihara, Kanagawa, Japan

Actively Recruiting

20

Yokosuka Kyosai Hospital

Yokosuka, Kanagawa, Japan

Actively Recruiting

21

Chikamori Hospital

Kochi, Kochi, Japan

Actively Recruiting

22

Kumamoto University Hospital

Kumamoto, Kumamoto, Japan

Actively Recruiting

23

Shinshu University Hospital

Matsumoto, Nagano, Japan

Actively Recruiting

24

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Not Yet Recruiting

25

Urasoe General Hospital

Urasoe, Okinawa, Japan

Actively Recruiting

26

The University of Tokyo Hospital

Bunkyo, Tokyo, Japan

Not Yet Recruiting

27

Moriyama Memorial Hospital

Edogawa City, Tokyo, Japan

Actively Recruiting

28

Sakakibara Heart Institute

Fuchū, Tokyo, Japan

Actively Recruiting

29

Jikei University Katsushika Medical Center

Katsushika-ku, Tokyo, Japan

Actively Recruiting

30

NTT Medical Center Tokyo

Shinagawa, Tokyo, Japan

Actively Recruiting

31

Keio University Hospital

Shinjuku, Tokyo, Japan

Not Yet Recruiting

32

Japanese Red Cross Wakayama Medical Center

Wakayama, Wakayama, Japan

Actively Recruiting

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Research Team

T

Takayuki Warisawa, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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