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

March 11, 2025 updated by: TCROSS Co., Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Chiba, Japan
        • Recruiting
        • Chiba University Hospital
        • Contact:
          • Yuichi Saito
      • Fukuoka, Japan
        • Not yet recruiting
        • National Hospital Organization Kyushu Medical Center
        • Contact:
          • Yoshinobu Murasato
      • Fukuoka, Japan
        • Recruiting
        • Fukuoka Wajiro Hospital
        • Contact:
          • Takeshi Serikawa
      • Gifu, Japan
        • Recruiting
        • Gifu Heart Center
        • Contact:
          • Yoshiaki Kawase
      • Kochi, Japan
        • Recruiting
        • Chikamori Hospital
        • Contact:
          • Ryu-Ichirou Imai
      • Kumamoto, Japan
        • Recruiting
        • Kumamoto University Hospital
        • Contact:
          • Kenichi Tsujita
      • Wakayama, Japan
        • Recruiting
        • Japanese Red Cross Wakayama Medical Center
        • Contact:
          • Junichi Tazaki
    • Aichi
      • Ichinomiya, Aichi, Japan
        • Recruiting
        • Ichinomiya Municipal Hospital
        • Contact:
          • Hisaaki Ishiguro
      • Toyoake, Aichi, Japan
        • Not yet recruiting
        • Fujita Health University School of Medicine
        • Contact:
          • Takashi Muramatsu
    • Chiba
      • Matsudo, Chiba, Japan
        • Recruiting
        • New Tokyo Hospital
        • Contact:
          • Koji Hozawa
      • Urayasu, Chiba, Japan
        • Recruiting
        • Tokyo Bay Urayasu Ichikawa Medical Center
        • Contact:
          • Masahiko Noguchi
    • Ehime
      • Matsuyama, Ehime, Japan
        • Recruiting
        • Ehime Prefectural Central Hospital
        • Contact:
          • Hideki Okayama
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Not yet recruiting
        • Kokura Memorial Hospital
        • Contact:
          • Takenori Domei
    • Gunma
      • Maebashi, Gunma, Japan
        • Not yet recruiting
        • Gunma University Hospital
        • Contact:
          • Takashi Nagasaka
    • Hokkaido
      • Hakodate, Hokkaido, Japan
        • Recruiting
        • Hakodate Municipal Hospital
        • Contact:
          • Yusuke Tokuda
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Sapporo Higashi Tokushukai Hospital
        • Contact:
          • Yuki Katagiri
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan
        • Recruiting
        • Tsuchiura Kyodo General Hospital
        • Contact:
          • Tsunekazu Kakuta
      • Tsukuba, Ibaraki, Japan
        • Not yet recruiting
        • Tsukuba Medical Center Hospital
        • Contact:
          • Hidetaka Nishina
    • Ishikawa
      • Kanazawa, Ishikawa, Japan
        • Recruiting
        • Kanazawa Cardiovascular Hospital
        • Contact:
          • Hidenobu Terai
    • Iwate
      • Morioka, Iwate, Japan
        • Recruiting
        • Memorial Heart Center Iwate Medical University
        • Contact:
          • Kai Ninomiya
    • Kanagawa
      • Kamakura, Kanagawa, Japan
        • Recruiting
        • Shonan Kamakura General Hospital
        • Contact:
          • Koki Shishido
      • Sagamihara, Kanagawa, Japan
        • Recruiting
        • Kitasato University School of Medicine
        • Contact:
          • Yoshiyasu Minami
      • Yokosuka, Kanagawa, Japan
        • Recruiting
        • Yokosuka Kyosai Hospital
        • Contact:
          • Tadashi Murai
    • Nagano
      • Matsumoto, Nagano, Japan
        • Recruiting
        • Shinshu University Hospital
        • Contact:
          • Yasushi Ueki
    • Okayama
      • Kurashiki, Okayama, Japan
        • Not yet recruiting
        • Kurashiki Central Hospital
        • Contact:
          • Hiroyuki Tanaka
    • Okinawa
      • Urasoe, Okinawa, Japan
        • Recruiting
        • Urasoe General Hospital
        • Contact:
          • Marohito Nakata
    • Tokyo
      • Bunkyo, Tokyo, Japan
        • Not yet recruiting
        • The University of Tokyo Hospital
        • Contact:
          • Hiroyuki Kiriyama
      • Edogawa, Tokyo, Japan
        • Recruiting
        • Moriyama Memorial Hospital
        • Contact:
          • Arihiro Kiyosue
      • Fuchu, Tokyo, Japan
        • Recruiting
        • Sakakibara Heart Institute
        • Contact:
          • Kenichi Hagiya
      • Katsushika, Tokyo, Japan
        • Recruiting
        • Jikei University Katsushika Medical Center
        • Contact:
          • Ryosuke Itakura
      • Shinagawa, Tokyo, Japan
        • Recruiting
        • NTT Medical Center Tokyo
        • Contact:
          • Takayuki Warisawa
      • Shinjuku, Tokyo, Japan
        • Not yet recruiting
        • Keio university hospital
        • Contact:
          • Yohei Numasawa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedure success rate
Time Frame: During PCI procedure

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
Time Frame: Within 12 months of PCI procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to ST-change from DCB inflation
Time Frame: During PCI procedure
confirming the time from the initiation of W-KBT to any ST elevation/depression in the electrocardiogram (ECG) to evaluate the safety of the procedure
During PCI procedure
Total DCB Inflation time
Time Frame: During PCI procedure
confirming the duration for which the inflation of the DCB can be sustained during W-KBT, as the recommendation time of DCB inflation is at least 30 seconds
During PCI procedure
Maximum changes in blood pressure and heart rate
Time Frame: During PCI procedure
confirming the extent of blood pressure and heart rate changes resulting from maintaining W-KBT for 30 seconds or longer in the left main coronary trunk (LMT)
During PCI procedure
Rate of use of vasopressors, inotropes, and mechanical circulatory support systems after W-KBT
Time Frame: During PCI procedure
confirming that hemodynamics is not disturbed by W-KBT for LMD
During PCI procedure
Incidence cases for each component of MACE and ischemia-driven unplanned revascularization for lesions at the LCx ostium
Time Frame: Within 12 months of PCI
confirming the frequency of occurrences for each component of MACE
Within 12 months of PCI

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of distal LAD coronary flow preservation during C-KBT vs. W-KBT
Time Frame: During PCI procedure
Fractional flow reserve (FFR) values will be measured before and after each KBT, using either a conventional balloon or PB
During PCI procedure
ST-change recovery time
Time Frame: During PCI procedure
confirming that ECG changes can easily recover even after W-KBT for LMD
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
Time Frame: Within 12 months of PCI
Within 12 months of PCI
Incidence of LM stent deformation after W-KBT assessed by intravascular ultrasound (IVUS)
Time Frame: During PCI procedure
During PCI procedure
MACE at 12 months based on lesion characteristics at the LCx ostial lesions and the type of lesion preparation step
Time Frame: Within 12 months of PCI
Within 12 months of PCI
Incidence of symptom onset during W-KBT and reviewing cases showing these symptoms
Time Frame: During PCI procedure
During PCI procedure
Incidence of Treatment Adverse Events [Safety and Tolerability] in patients with low left ventricular ejection fraction (LVEF)
Time Frame: During PCI procedure & Within 12 months of PCI
The incidence rate will be calculated using the median LVEF or 40% as the cutoff
During PCI procedure & Within 12 months of PCI
The procedural success rate based on the number of LM-PCI experiences
Time Frame: During PCI procedure & Within 12 months of PCI
comparing efficacy and safety among various groups based on PCI operators' experience
During PCI procedure & Within 12 months of PCI
Late lumen loss
Time Frame: During PCI procedure & Within 12 months of PCI
in balloon dilated coverage area of the side branch lesion measured by QCA (Quantitative Coronary Angiography)
During PCI procedure & Within 12 months of PCI
Assessment of ischemia including FFR or non-hyperemic pressure ratios (NHPRs) at follow-up visit
Time Frame: Within 12 months of PCI
Within 12 months of PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TCROSS Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kaneka Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JDEPTH-LM Registry
  • jRCT1030240071 (Other Identifier: Japan Registry of Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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